Rubeosis Anti-VEGF (RAVE) Trial for Ischemic Central Retinal Vein Occlusion

Completed · Phase 1

Conditions studied: Ischemic Central Retinal Vein Occlusion

In brief

The RAVE (Rubeosis Anit-VEgf) trial, utilizes monthly intravitreal Ranibizumab (Lucentis) injections for 9 months to see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic central retinal vein occlusion.

Key facts

Study ID

NCT00406471

Run by

Greater Houston Retina Research

People needed

20

Starts

2005-05-01

Expected to finish

2011-01-01

Last updated by the study team

2013-03-14

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 18 years
• Ischemic CRVO within 3 months of enrollment as per the following inclusion criteria
• Three of the following clinical tests must be present to demonstrate ischemic CRVO:
• VA 20/200 or worse
• RAPD 0.9 LU or worse
• Loss of 1-2e isopter on Goldmann Visual field (Kwon et al. 2001)
• ERG demonstrating b wave amplitude less than 60% of A wave

You may not qualify if…

• Angle neovascularization greater than 3 clock hours with IOP over 30 (Neovascular glaucoma)
• Any previous retinal laser photocoagulation to the study eye
• Any previous intravitreal injection in study eye (triamcinolone or other)
• Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery)
• Intracapsular cataract extraction (posterior capsule needs to be present)
• Previous history of retinal detachment in study eye
• Any previous radiation treatments to head/ neck
• Inability to assess iris neovascularization (corneal opacity precluding gonioscopy)
• Significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study
• Significant diabetic retinopathy in the fellow eye (diabetic macular edema, proliferative diabetic retinopathy, or high-risk non-proliferative diabetic retinopathy)
• Pregnancy (positive pregnancy test)
• Prior enrollment in any study for vein occlusion in the study eye
• Participation in another simultaneous medical investigator or trial
• Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., DME AMD, ocular histoplasmosis, or pathologic myopia)
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period
• Aphakia or absence of the posterior capsule in the study eye
• Previous violation of the posterior capsule is also excluded unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
• History of idiopathic or autoimmune uveitis in either eye
• Structural damage to the center of the macula in the study eye preexisting to CRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s)
• Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
• Ocular inflammation (including trace or above) in the study eye
• Uncontrolled glaucoma (defined as intraocular pressure ≥30 mm Hg despite treatment with anti- medications) or previous filtration surgery in the study eye
• Infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection
• Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia (For patients who have had refractive or cataract surgery in the study eye, pre-operative spherical equivalent refractive error of more than -8 diopters myopia is not allowed) Systemic Conditions
• Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period

Where it is running

• Vitreoretinal Consultants — Houston, Texas, United States

Full record on ClinicalTrials.gov

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