Intraocular Bevacizumab (Avastin) for Rubeosis Iridis

NCT00557232 | Completed Phase 4 DMC

• 1 other identifier: JN-01-2007-ARVO
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glaucoma; Rubeosis Iridis

Keywords

bevacizumab; rubeosis iridis; glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

bevacizumab DRUG

1.25mg/month

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Instituto de Olhos de Goiania: lead

MeSH Terms

Conditions

Glaucoma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joao J Nassaralla, Jr.

  Instituto de Olhos de Goiânia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 12, 2007
• Study Start: November 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 29, 2011

Record last verified: 2011-11