Search

Current Research on Retinal Vein Occlusion

RETINAL VEIN OCCLUSION

Study: TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

ClinicalTrials.gov Identifier: NCT03093701

Sponsor: Taiwan Liposome Company

Purpose: Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.

Design: Randomized, parallel assignment, quadruple masking

Number of Patients: 61

Inclusion Criteria: Male or female, at least 18 years of age. Macular edema due to CRVO or BRVO. Best-corrected visual acuity (BCVA) score of 20/40 to 20/400. Mean central subfield thickness (CST) ≥350 um. Willing and able to comply with the study procedure and sign a written informed consent. Agree to use a medically acceptable form of birth control.

Exclusion Criteria: Poorly controlled diabetes. History of significant intraocular pressure (IOP) elevation to steroid treatment. History of ocular hypertension and glaucoma. Cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening. Use of hemodilution for the treatment of RVO. Use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to screening; or IVT aflibercept within 8 weeks prior to screening. IVT Ozurdex to the study eye within 6 months prior to screening. Prior use of Retisert or Iluvien. Use of systemic steroids or heparin within 1 month prior to screening.

Paused due to COVID-19 Study: Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (RAVEN)

ClinicalTrials.gov Identifier: NCT03810313

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).

Design: Randomized, parallel assignment, triple masking

Number of Patients: 750

Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Patients with visual impairment due to ME secondary to CRVO diagnosed < 6 months prior to screening. BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits.

Exclusion Criteria: Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than CRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline. Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract). Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline. Previous use of intraocular or periocular steroids in study eye at any time prior to baseline. Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline. Intraocular surgery in the study eye during the 3‑month period prior to baseline. Vitreoretinal surgery in the study eye at any time prior to baseline. Aphakia with the absence of posterior capsule in the study eye.

Information: novartis.email@novartis.com

Paused due to COVID-19 Study: Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (RAPTOR)

ClinicalTrials.gov Identifier: NCT03802630

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

Design: Randomized, parallel assignment, triple masking

Number of Patients: 500

Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Patients with visual impairment due to ME secondary to BRVO diagnosed < 6 months prior to screening. BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits.

Exclusion Criteria: Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than BRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion should be excluded. Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline. Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract). Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline. Previous use of intraocular or periocular steroids in study eye at any time prior to baseline. Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline. Intraocular surgery in the study eye during the 3‑month period prior to baseline. Vitreoretinal surgery in the study eye at any time prior to baseline. Aphakia with the absence of posterior capsule in the study eye.

Information: novartis.email@novartis.com

Study: Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

ClinicalTrials.gov Identifier: NCT04120636

Sponsor: Targeted Therapy Technologies, LLC

Purpose: This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.

Design: Single group, no masking

Number of Patients: 3

Inclusion Criteria: Age ≥18 years; Visual acuity letter score in study eye <70 and ≥25 letters (approximate Snellen equivalent 20/32 to 20/320); ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF); inflammatory disorders of the sclera, choroid, retina or vitreous.

Exclusion Criteria: Inability to understand informed consent, cooperate with testing or return to follow-up visits; pregnant or lactating women; co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.

Study: Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

ClinicalTrials.gov Identifier: NCT04120311

Sponsor: Targeted Therapy Technologies, LLC

Purpose: This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.

Design: Single group, no masking

Number of Patients: 3

Inclusion Criteria: Age ≥18 years; Visual acuity letter score in study eye <70 and ≥25 letters (approximate Snellen equivalent 20/32 to 20/320); ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF); inflammatory disorders of the sclera, choroid, retina or vitreous.

Exclusion Criteria: Inability to understand informed consent, cooperate with testing or return to follow-up visits; pregnant or lactating women; co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.

Study: A Depot Formulation of Sunitinib Malate (GB-102) in Subjects with Diabetic Macular Edema and Retinal Vein Occlusion

ClinicalTrials.gov Identifier: NCT04085341

Sponsor: Graybug Vision

Purpose: Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects with diabetic macular edema and retinal vein occlusion.

Design: Nonrandomized, parallel assignment, no masking

Number of Patients: 20

Inclusion Criteria: Males or females ≥21 years of age. Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab). Demonstrated response to prior anti-VEGF treatment since diagnosis. BCVA of 31 letters or better.

Exclusion Criteria: History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke. Uncontrolled hypertension, diabetes mellitus or IOP. Chronic renal disease.

Information: vsmith@graybug.com

Paused due to COVID-19 Study: Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients with Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (RAVEN)

ClinicalTrials.gov Identifier: NCT03810313

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).

Design: Randomized, parallel assignment, triple masking

Number of Patients: 750

Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Patients with visual impairment due to ME secondary to BRVO diagnosed <6 months prior to screening. BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits.

Exclusion Criteria: Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (eg structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than BRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion should be excluded. Any active intraocular or periocular infection or active intraocular inflammation (eg infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) >25 mmHg on medication, or according to investigator's judgment, at screening or baseline. Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200 at screening (except when due to conditions whose surgery may improve VA, eg cataract). Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline. Previous use of intraocular or periocular steroids in study eye at any time prior to baseline. Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline. Intraocular surgery in the study eye during the 3‑month period prior to baseline. Vitreoretinal surgery in the study eye at any time prior to baseline. Aphakia with the absence of posterior capsule in the study eye.

Information: novartis.email@novartis.com

Study: Treatment of Central Retinal Vein Occlusion Using Stem Cells Study (TRUST)

ClinicalTrials.gov Identifier: NCT03981549

Sponsor: The Emmes Company, LLC

Purpose: This study evaluates whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later, while the other half will receive immediate sham therapy followed by cellular therapy 6 months later. Participants will be followed for a total of 2 years.

Design: Randomized, parallel assignment, triple masking

Number of Patients: 20

Inclusion Criteria: Clinical diagnosis of central retinal vein occlusion (CRVO) confirmed by review of medical records and screening assessment. Best Corrected Visual Acuity (BCVA) obtained during the screening period is in the range of 20/60+ to 20/400- (ETDRS letter score in the range of 18 to 63, inclusive). Duration of vision loss from CRVO ≥6 months to 3 years.

Exclusion Criteria: Previous eye treatment with intravitreal or periocular steroids, intravitreal injection, laser or intraocular surgery within 6 months prior to enrollment (ie, date ICF signed) or treatment expected during the study period. History of concurrent ocular herpes infection. Active non-herpetic eye infection diagnosed within 8 weeks from enrollment (ie, date Informed Consent Form (ICF) signed). Glaucoma requiring treatment with more than 1 medication, laser or intraocular surgery. Active uveitis or history of recurrent uveitis or uveitis involving the posterior segment. Presence of cataract that is impairing vision. Presence of lens or lens implant subluxation. History of ocular trauma that is currently impairing vision. History or concurrent optic nerve or retinal disease, including macular degeneration, myopic degeneration, retinitis pigmentosa, retinal tear or detachment. Active retinal or iris neovascularization. Macular edema requiring on-going therapy or where treatment is expected during the study period. Significant media opacity precluding view of the fundus for examination, photography or optical coherence tomography (OCT) including cataract and vitreous haze. High myopia (>9 diopters); Amblyopia; Other cause contributing to vision loss at screening. History of any of the following procedures: corneal transplant, glaucoma surgery, photodynamic therapy, retinal cryopexy, pneumatic retinopexy, intraocular oil or scleral buckle.

Information: dcmacias@ucdavis.edu, mesalvador@ucdavis.edu

Study: TLC399 (ProDex) in Subjects with Macular Edema Due to Retinal Vein Occlusion (RVO)

ClinicalTrials.gov Identifier: NCT03093701

Sponsor: Taiwan Liposome Company

Purpose: Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.

Design: Randomized, parallel assignment

Number of Patients: 61

Inclusion Criteria: Male or female, at least 18 years of age; macular edema due to CRVO or BRVO; best-corrected visual acuity (BCVA) score of 20/40 to 20/400; mean central subfield thickness (CST) ≥350 um; willing and able to comply with the study procedure and sign a written informed consent; agree to use a medically acceptable form of birth control.

Exclusion Criteria: Poorly controlled diabetes; history of significant intraocular pressure (IOP) elevation to steroid treatment; history of ocular hypertension and glaucoma; cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening; use of hemodilution for the treatment of RVO; use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to screening; or IVT aflibercept within 8 weeks prior to screening; IVT Ozurdex to the study eye within 6 months prior to screening; prior use of Retisert or Iluvien; use of systemic steroids or heparin within 1 month prior to screening.

Study: Post Intravitreal Injection Topical NSAID vs Patching

ClinicalTrials.gov Identifier: NCT03918590

Sponsor: The New York Eye & Ear Infirmary

Purpose: A prospective randomized trial, to evaluate postinjection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.

Design: Randomized, parallel assignment

Number of Patients: 60

Inclusion Criteria: 18 years of age or older; Already scheduled for anti-VEGF injection based on standard of care for disease process. Ability to provide written informed consent; Capable of complying with study protocol. Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care.

Exclusion Criteria: History of past intraocular injection of steroid medication. Experiencing baseline eye pain; Monocular; non-study eye with VA<20/100. Unwilling or unable to follow or comply with all study related procedures.

Study: Study Assessing AR-1105 in Subjects with Macular Edema Due to Retinal Vein Occlusion (RVO)

ClinicalTrials.gov Identifier: NCT03739593

Sponsor: Aerie Pharmaceuticals

Purpose: This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO). A more durable intravitreal implant containing a low dose of dexamethasone may result in less frequent retreatments, and potentially lower the incidence of steroid-related side effects without compromising efficacy.

Design: Randomized, parallel assignment, no masking

Number of Patients: 40

Inclusion Criteria: At least 18 years of age; Vision loss due to clinically detectable macular edema (ME) associated with either central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). Subjects may be treatment-naïve, or if previously-treated with a steroid, must have demonstrated response to treatment; Duration of macular edema (ME) ≥9 months in subjects with CRVO and ≥12 months in subjects with BRVO. If both eyes are eligible, the study eye will be the eye with worse VA; Best-corrected visual acuity (BCVA) as measured by the early treatment of diabetic retinopathy study (ETDRS) methodology of between 25 and 70 letters, in the study eye and better than 35 letters, in the non-study eye; Retinal thickness in the central subfield of >290 µm (females) and >305 μm (males) if using a Cirrus (Zeiss) instrument, or if a Spectralis (Heidelberg) instrument is used, thickness should be >305 μm (females) or >320 μm (males) in the study eye; Be able to understand and willing to provide written informed consent. Be willing and able to adhere to the instructions set forth in the study protocol.

Exclusion Criteria: Ophthalmic: Presence of a clinically significant epiretinal membrane, active retinal or optic disc neovascularization, active or history of choroidal neovascularization, presence of rubeosis iridis; History or presence of herpetic infection, toxoplasmosis, chorioretinopathy. Subjects with moderate non-proliferative diabetic retinopathy or worse in either eye are excluded from participation; Any active infection; Aphakia, significant posterior capsule tear or iris trauma in the study eye; Anterior-chamber intraocular lens; Clinically significant media opacity; History of glaucoma or visual field loss; Ocular hypertension in the study eye at qualification, (with or without treatment); History of corticosteroid-induced IOP increase in either eye; Ocular condition in the study eye that, in the opinion of the investigator, would prevent a 15-letter improvement in visual acuity; Received an intraocular steroid injection or implant within 6 months or any anti-VEGF treatment within 2 months prior to screening. Prior treatment with RETISERT or ILUVIEN or panretinal photocoagulation (PRP) is exclusionary; Intraocular surgery (including laser refractive or eyelid surgery) within 3 months prior to visit 1 or anticipated need for ocular surgery or ophthalmic laser treatment during the study treatment period; Currently using topical corticosteroids in the vicinity of the eyes within the 1 month prior to visit 1; Periocular depot of steroids placed within 6 months prior to qualification; Ocular medications that are specifically disallowed in this protocol for any condition during the study or within the specified timeframe prior to visit 2’ Have progressive optic nerve disease or retinal disease other than retinopathy due to RVO that affects BCVA. Systemic: Currently using or anticipating the use of systemic corticosteroids during the study (with the exception of inhaled, intranasal or topical corticosteroids); Any clinically significant or uncontrolled serious or severe medical or psychiatric condition; Participation in any other clinical study within 30 days prior to visit 1; History of hypersensitivity or poor tolerance to any components of the preparations to be used in this study such as dexamethasone or biodegradable polymer (PLGA) excipients or fluorescein; Systemic condition that may confound the study outcome per the investigator's opinion; Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Information: nramirez@aeriepharma.com; jlopez@aeriepharma.com

Study: Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)

ClinicalTrials.gov Identifier: NCT01969708

Sponsor: The EMMES Corporation

Purpose: SCORE2 is a multicenter, prospective, randomized, phase III clinical trial in which all participants enrolled will be followed for up to 2.5 years. SCORE2 is designed as a non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25 mg) every 4 weeks vs intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine if bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated with central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured at month 6.

Design: Randomized, parallel assignment, single masking

Number of Patients: 362

Inclusion Criteria: Participants must have center-involved macular edema secondary to CRVO. Eyes may be enrolled as early as the time of diagnosis of the macular edema. The definition of CRVO used in SCORE will also be used for the purposes of SCORE2: a CRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (eg, telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in all 4 quadrants. Due to the similarities of a hemiretinal vein occlusion (HRVO) to CRVO, HRVO will be classified as CRVO for the purposes of this clinical trial. Eyes classified as having a HRVO will be limited to no more than 25% of the planned sample size. A HRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (eg telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in 5 or more clock hours but less than all 4 quadrants. Typically, a HRVO is a retinal vein occlusion that involves 2 altitudinal quadrants. E-Early Treatment Diabetic Retinopathy Study (ETDRS)visual acuity score of greater than or equal to 19 letters (approximately 20/400) and less than or equal to 73 letters (approximately 20/40) by the ETDRS visual acuity protocol. The investigator must believe that a study eye with visual acuity between 19 and 33 letters is perfused. Retinal thickness on SD-OCT measurement, defined as central subfield thickness of 300 µm or greater. If the SD-OCT measurement is taken from a Heidelberg Spectralis Machine, the central subfield thickness should be 320 µm or greater. Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.

Exclusion Criteria: A condition that, in the opinion of the investigator, would preclude participation in the study (eg, chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers indicating difficulty in long term follow-up, likelihood of survival of less than 12 months). Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at time of study entry. History of allergy to any anti-VEGF agent, corticosteroid, or component of the delivery vehicle. The participant will be moving out of the area of the clinical site to an area not covered by another clinical site during the 12 months of the study. Positive urine pregnancy test: all women of childbearing potential (those who are premenopausal and not surgically sterilized) may participate only if they have a negative urine pregnancy test, and if they do not intend to become pregnant during the timeframe of the study. Women who are sexually active with a male partner must agree to use at least one of the following birth control methods: hormonal therapy such as oral, implantable or injectable chemical contraceptives; mechanical therapy such as spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner. Women who are breast-feeding. Examination evidence of vitreoretinal interface disease (eg, vitreomacular traction, epiretinal membrane), either on clinical examination or OCT thought to be contributing to macular edema. An eye that, in the investigator's opinion, would not benefit from resolution of macular edema such as eyes with foveal atrophy, dense pigmentary changes or dense subfoveal hard exudates. Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (eg, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, iris neovascularization, Irvine-Gass Syndrome, prior macula-off rhegmatogenous retinal detachment). Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (ie, a 20/40 cataract). History of laser photocoagulation for macular edema within 3 months prior to randomization. History of intravitreal corticosteroid within 4 months of randomization. Intravitreal anti-VEGF injection within 2 months of randomization. Note: Enrollment will be limited to no more than 25% of the planned sample size with any history of anti-VEGF treatment. Once this number of eyes has been enrolled, any history of anti-VEGF treatment will be an exclusion criterion. For enrollment of study eyes with prior intravitreal anti-VEGF agents, in the opinion of the investigator, the treatment response to prior anti-VEGF treatment must be either incomplete or the study eye had developed recurrent CRVO-associated macular edema, such that the study eye would benefit from additional anti-VEGF treatment. History of peribulbar or retrobulbar corticosteroid use for any reason within 2 months prior to randomization. History of panretinal scatter photocoagulation (PRP) or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 3 months following randomization. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within 4 months prior to randomization or anticipated within the next 6 months following randomization. History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization. Aphakia. Presence of an anterior chamber intraocular lens. Examination evidence of external ocular infection, including conjunctivitis, chalazion or significant blepharitis. History of macular detachment. Examination evidence of any diabetic retinopathy.

Information: https://secure.emmes.com/scoreweb

Study: Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO

ClinicalTrials.gov Identifier: NCT03790852

Sponsor: Kodiak Sciences, Inc.

Purpose: This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at 2 dose levels: 2.5 mg and 5 mg.

Design: Randomized, parallel assignment, no masking

Number of Patients: 50

Inclusion Criteria: RVO Cohort: Treatment naïve retinal vein occlusion with macular edema and secondary visual impairment. BCVA ETDRS letter score ≤78 and ≥23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye. Central subfield thickness (CST) of ≥300 microns on SD-OCT (Heidelberg Spectralis or equivalent). Branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) are both eligible. Decrease in vision in the study eye determined by the investigator to be primarily the result of macular edema secondary to RVO.

Exclusion Criteria: RVO Cohort: Initial diagnosis of RVO of more than 4 months from screening in the study eye. Active retinal or iris neovascularization in the study eye. Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.

Information: jehrlich@kodiak.com, pablovm@kodiak.com

1 view0 comments

Recent Posts

See All

Current Research on Uveitis

UVEITIS NEW Study: Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (STACCATO) ClinicalTrials.gov Identifier: NCT03586284 Sponsor: University of Cal

Current Research on Diabetic Macular Edema

DIABETIC MACULAR EDEMA Study: This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) C

Current Research on Wet AMD

WET AMD A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD (PHTHALO-205) ClinicalTrials.gov Identifier: NCT04331730 Sponsor: Alkahest, Inc. P