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AzTrials

GlaucomaPhase 4NCT00557232

Intraocular Bevacizumab (Avastin) for Rubeosis Iridis

A Phase 4 study testing bevacizumab in people with Glaucoma and Rubeosis Iridis, run by Instituto de Olhos de Goiania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Glaucoma, Rubeosis Iridis
What is being tested?
bevacizumab
How many people
25 participants
Where
No sites listed yet
Study dates
Nov 2006to Nov 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

About this study

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

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.

Being tested
bevacizumab
Keywords
bevacizumab, rubeosis iridis, glaucoma
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Compare results

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionOct 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00557232
Sponsor's protocol ID
JN-01-2007-ARVO
Status last verified
Nov 2011
First submitted
8 Nov 2007
Last updated
29 Nov 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing bevacizumab in people with Glaucoma and Rubeosis Iridis, run by Instituto de Olhos de Goiania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Bevacizumab (Avastin) for Rubeosis Iridis (time frame: Compare results). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00557232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.

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