Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO

Completed · Phase 4

Conditions studied: Retinal Vein Occlusion, Diabetic Macular Edema, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion

In brief

This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and optical coherence tomography (OCT) angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.

Key facts

Study ID

NCT02503540

Run by

Justis Ehlers

People needed

31

Starts

2015-08-18

Expected to finish

2018-02-06

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A subject must meet the following criteria to be eligible for inclusion in the study:
• Signed Informed Consent.
• Men and women ≥ 18 years of age.
• Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SDOCT.
• E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye or Hand Motion (HM) in the study eye.
• Willing, committed, and able to return for all clinic visits and complete all study related procedures.
• Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

You may not qualify if…

• A subject who meets any of the following criteria will be excluded from the study:
• Any prior or concomitant therapy with another investigational agent to treat DME or RVO in the study eye.
• Prior panretinal photocoagulation in the study eye.
• Prior intravitreal anti-VEGF therapy in the study eye.
• Prior focal/grid laser photocoagulation in the study eye.
• Prior history of intravitreal steroid therapy in the study eye.
• Any history of allergy to fluorescein sodium or other reason that the patient is unable to undergo fluorescein angiography (e.g., inability to get vascular access, unable to tolerate procedure)
• Prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
• Significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam and ultra-widefield angiography.
• Presence of other causes of macular edema, including myopic degeneration, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, choroidal neovascularization, neovascular age-related macular degeneration or multifocal choroiditis in the study eye. Epiretinal membranes are allowed.
• Presence of macula-threatening traction retinal detachment.
• Prior vitrectomy in the study eye.
• History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
• Any history of macular hole of stage 2 and above in the study eye.
• Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
• Prior trabeculectomy or other filtration surgery in the study eye.
• Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
• Active intraocular inflammation in either eye.
• Active ocular or periocular infection in either eye.
• Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
• Any history of uveitis in either eye.
• Active scleritis or episcleritis in either eye.
• Presence or history of scleromalacia in either eye.
• Aphakia in the study eye.
• Previous therapeutic radiation in the region of the study eye.

Where it is running

• Cole Eye Institute, Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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