Know Cancer

or
forgot password

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


Phase 4
18 Years
65 Years
Not Enrolling
Both
Glaucoma, Rubeosis Iridis

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Intraocular Bevacizumab (Avastin) for Rubeosis Iridis

Outcome Description:

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

Outcome Time Frame:

Compare results

Safety Issue:

Yes

Principal Investigator

Joao J Nassaralla, Jr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto de Olhos de Goiânia

Authority:

Brazil: National Health Surveillance Agency

Study ID:

JN-01-2007-ARVO

NCT ID:

NCT00557232

Start Date:

November 2006

Completion Date:

November 2011

Related Keywords:

  • Glaucoma
  • Rubeosis Iridis
  • bevacizumab
  • rubeosis iridis
  • glaucoma
  • Glaucoma
  • Glaucoma, Neovascular
  • Retinal Vein Occlusion

Name

Location