Intraocular Bevacizumab (Avastin) for Rubeosis Iridis

November 25, 2011 updated by: Joao Nassaralla, Instituto de Olhos de Goiania

The RAVE (Rubeosis Anit-VEgf) Trial, Utilizes Monthly Intravitreal Bevazizumab (Avastin) Injections for 12 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

Bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) is an anti-VEGF recombinant humanized monoclonal IgG1 antibody used to treat colorectal cancers. Bevacizumab may have a role in treating ocular disorders involving fibrovascular proliferation. To determine whether intraocular bevacizumab decreases rubeosis iridis in patients with neovascular glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Systemic Conditions
  • Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period
  • Uncontrolled diabetes mellitus
  • Renal failure requiring dialysis or renal transplant
  • Premenopausal women not using adequate contraception
  • Previous participation in other studies of investigational drugs (excluding vitamins and minerals) within 3 months preceding Day 0
  • History of other disease, metabolic dysfunction, physical examination finding, or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Bevacizumab (Avastin) for Rubeosis Iridis
Time Frame: Compare results
RI was investigated prospectively by iris biomicroscopy. An expanded informed consent with an off-label use waiver and explanation letter was reviewed with all patients
Compare results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Olhos de Goiania

Investigators

  • Principal Investigator: Joao J Nassaralla, Jr., Instituto de Olhos de Goiania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 8, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 25, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JN-01-2007-ARVO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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