Ended Therapeutic confirmatory (Phase III) Macular edema secondary to retinal vein occlusion

A study to learn how well a higher amount of aflibercept given as an injection into the eye works and how safe it is in people with reduced vision due to swelling in the macula, central part of the retina caused by a blocked vein in the retina (macula edema secondary to retinal vein occlusion)

EU CTIS ID: 2022-502174-16-00

What this study is testing

To determine if treatment with aflibercept 8 mg every 8 weeks (Q8W) provides non-inferior best-corrected visual acuity (BCVA) change compared to aflibercept 2 mg every 4 weeks (Q4W)

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Adult ≥18 years of age (or country’s legal age of adulthood if the legal age is >18 years) at the time of signing the informed consent
  • Treatment-naïve macular edema involving the foveal center secondary to retinal vein occlusion (RVO) (branch RVO (BRVO), hemiretinal vein occlusion (HRVO), or central RVO (CRVO)) diagnosed within 16 weeks (112 days) before the screening visit in the study eye.
  • Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye.
  • Decrease in BCVA determined to be primarily the result of RVO in the study eye.
  • Mean central subfield thickness (CST) ≥300 µm on optical coherence tomography (OCT) if excluding Bruch’s membrane (e.g., Cirrus or Topcon) or ≥320 µm if including Bruch’s membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye.
  • Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

You likely can't join if

  • Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye.
  • Prior treatment of the study eye with any of the following drugs (any route of ophthalmic administration) or procedures: a. Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies). b. Previous use topical steroids within 4 weeks (28 days) from the screening visit, or intraocular or periocular steroids within 16 weeks (112 days) from the screening visit, or steroid implants at any time. c. Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time. d. Treatment with ocriplasmin at any time. e. Vitreoretinal surgery (including scleral buckling) at any time. f. Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit. g. Previous treatment with retinal laser photocoagulation.
  • Prior treatment of the fellow eye with any of the following: a. Gene therapy, or cell therapy in the fellow eye at any time.
  • Participation in other clinical studies requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening visit, or within 30 days or 5 half-lives of administration of the previous study intervention, whichever is longer.
  • Presence or history of the following ocular conditions: a. Advanced age-related macular degeneration (neovascular AMD or geographic atrophy) in the study eye. b. Diabetic macular edema or diabetic retinopathy, defined in diabetic participants as diabetic retinopathy lesions outside the area of the vein occlusion in the study eye and anywhere in the retina in the fellow eye. c. Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in the study eye. d. Vitreomacular traction, epiretinal membrane or structural damage to the macula that is considered by the Investigator to significantly affect central vision or preclude improvement in vision in the study eye. e. Macular hole of stage 2 and above in the study eye. f. Myopia of a spherical equivalent of at least 8 diopters prior to any refractive or cataract surgery in the study eye. g. Corneal transplant or corneal dystrophy in the study eye. h. Idiopathic or autoimmune uveitis in the study or in the fellow eye."
  • Presence of the following ocular conditions at screening or baseline visit: a. Significant media opacities, including cataract, that interfere with BCVA, or imaging assessments (e.g., fundus photography [FP], optical coherence tomography (OCT)) in the study eye. b. Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium-aluminum-garnet [YAG] posterior capsulotomy performed more than 30 days before the screening visit), in the study eye. c. Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication); or history or likely future need of glaucoma surgery in the study eye. d. Intraocular inflammation/infection (including trace, or above, cells in the anterior chamber and/or vitreous) within 12 weeks (84 days) of the screening visit in the study or in the fellow eye. e. Extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in the study or in the fellow eye.
See the full eligibility criteria
Who can join
  • Adult ≥18 years of age (or country’s legal age of adulthood if the legal age is >18 years) at the time of signing the informed consent
  • Treatment-naïve macular edema involving the foveal center secondary to retinal vein occlusion (RVO) (branch RVO (BRVO), hemiretinal vein occlusion (HRVO), or central RVO (CRVO)) diagnosed within 16 weeks (112 days) before the screening visit in the study eye.
  • Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye.
  • Decrease in BCVA determined to be primarily the result of RVO in the study eye.
  • Mean central subfield thickness (CST) ≥300 µm on optical coherence tomography (OCT) if excluding Bruch’s membrane (e.g., Cirrus or Topcon) or ≥320 µm if including Bruch’s membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye.
  • Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • US participants will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws.
  • Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set on protocol.
What rules you out
  • Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye.
  • Prior treatment of the study eye with any of the following drugs (any route of ophthalmic administration) or procedures: a. Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies). b. Previous use topical steroids within 4 weeks (28 days) from the screening visit, or intraocular or periocular steroids within 16 weeks (112 days) from the screening visit, or steroid implants at any time. c. Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time. d. Treatment with ocriplasmin at any time. e. Vitreoretinal surgery (including scleral buckling) at any time. f. Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit. g. Previous treatment with retinal laser photocoagulation.
  • Prior treatment of the fellow eye with any of the following: a. Gene therapy, or cell therapy in the fellow eye at any time.
  • Participation in other clinical studies requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening visit, or within 30 days or 5 half-lives of administration of the previous study intervention, whichever is longer.
  • Presence or history of the following ocular conditions: a. Advanced age-related macular degeneration (neovascular AMD or geographic atrophy) in the study eye. b. Diabetic macular edema or diabetic retinopathy, defined in diabetic participants as diabetic retinopathy lesions outside the area of the vein occlusion in the study eye and anywhere in the retina in the fellow eye. c. Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in the study eye. d. Vitreomacular traction, epiretinal membrane or structural damage to the macula that is considered by the Investigator to significantly affect central vision or preclude improvement in vision in the study eye. e. Macular hole of stage 2 and above in the study eye. f. Myopia of a spherical equivalent of at least 8 diopters prior to any refractive or cataract surgery in the study eye. g. Corneal transplant or corneal dystrophy in the study eye. h. Idiopathic or autoimmune uveitis in the study or in the fellow eye."
  • Presence of the following ocular conditions at screening or baseline visit: a. Significant media opacities, including cataract, that interfere with BCVA, or imaging assessments (e.g., fundus photography [FP], optical coherence tomography (OCT)) in the study eye. b. Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium-aluminum-garnet [YAG] posterior capsulotomy performed more than 30 days before the screening visit), in the study eye. c. Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication); or history or likely future need of glaucoma surgery in the study eye. d. Intraocular inflammation/infection (including trace, or above, cells in the anterior chamber and/or vitreous) within 12 weeks (84 days) of the screening visit in the study or in the fellow eye. e. Extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in the study or in the fellow eye.
  • Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg) at screening visit or baseline visit.
  • Uncontrolled diabetes mellitus, defined by hemoglobin A1c (HbA1c) >12% at the screening visit.
  • History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) before the screening visit or between screening and baseline visits.
  • Renal failure requiring dialysis, or renal transplant at screening or potentially during the study.
  • Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for RVO in the study eye.
  • Previous administration of systemic anti-angiogenic medications for any condition.

The study team makes the final eligibility decision.

Where it's taking place

  • China
  • Turkey
  • Thailand
  • Georgia
  • Switzerland
  • Serbia
  • Australia
  • Israel
  • Mexico
  • Malaysia
  • United Kingdom
  • United States
  • Japan
  • Korea, Republic of

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include China; Turkey; Thailand; Georgia; Switzerland; Serbia and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.