Intraocular Bevacizumab (Avastin) for Rubeosis Iridis

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557232
• Other study ID #: JN-01-2007-ARVO
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2007
• Last updated: November 25, 2011
• Start date: November 2006
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Rubeosis Iridis

Intervention

Drug:
• bevacizumab
1.25mg/month

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Bevacizumab (Avastin) for Rubeosis Iridis	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	Yes