Intravitreal Avastin Versus Intravitreal Avastin and Triamcinolone in Central Retinal Vein Occlusion(CRVO)

Condition(s) targeted: Retinovascular Disease

Intervention: Avastin (Bevacizumab) and triamcinolone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Shaheed Beheshti Medical University

Official(s) and/or principal investigator(s):
Siamak Moradian, MD, Principal Investigator, Affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University

Overall contact:
Siamak Moradian, MD, Phone: +98 21 22585952, Email: labbafi@hotmail.com

In this study we intend to evaluate and compare the outcomes of intravitreal avastin versus avastin and triamcinolone on improving the visual acuity and macular edema and late complications of CRVO like NVI and NVG.

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Best corrected visual acuity

Macular thickness by OCT

Secondary outcome: Incidence of NVI

Detailed description: Central retinal vein occlusion (CRVO) is a common retinal vascular disorder with potentially complications like reduced vision resulting from extensive intraretinal hemorrhage, retinal ischemia and persistent macular edema and neovascular glaucoma secondary to iris neovascularization. Macular edema is a common cause of severe visual loss in both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). Natural history data indicate that CRVO patients presenting with poor visual acuity (_20/200) have an 80% chance of being left with visual acuity less than 20/200 at final visit, whether the CRVO is ischemic or nonischemic at presentation. Treatments that target the secondary effects of venous occlusion, such as grid laser photocoagulation for macular edema and prophylactic panretinal laser photocoagulation for nonperfused CRVO, were shown to be ineffective in improving visual acuity in the Central Vein Occlusion Study (CVOS). Although panretinal photocoagulation is advocated for reducing the risk of neovascular glaucoma in patients with ischemic CRVO, recent clinical trials have failed to demonstrate any significant benefit with laser photocoagulation in the treatment of macular edema due to CRVO. A number of other treatment options are sometimes used in cases of CRVO, such as oral corticosteroids, intravitreal steroids, vitrectomy, hemodilution, intravitreal tissue plasminogen activator, hyperbaric oxygen, and laser or surgical chorioretinal anastomosis. Studies demonstrating the effectiveness of these treatments are inconclusive, although some benefits have been suggested in recent reports. In recent studies the benefit of antiVEGF agents in improving the macular edema due to CRVO have been shown. In this study we are going to compare the effect of intravitreal antiVEGF (Avastin) with combination of Avastin and Triamcinolon in improving the visual acuity and macular thickness in patients with recent (Less than 6 months) CRVO.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- CRVO with duration less than 6 months

Exclusion Criteria:

- vision less than 20/320 and vison more than 20/50

- history of galucoma and diabetic retinopathy

- previous laser or intravitreal treatment

- any media opacity that prevents funduscopy

Siamak Moradian, MD, Phone: +98 21 22585952, Email: labbafi@hotmail.com

Siamak Moradian, MD, Tehran 16666, Iran, Islamic Republic of; Recruiting
Siamak Moradian, MD, Phone: +98 21 22585952, Email: labbafi@hotmail.com

Starting date: August 2006
Ending date: February 2007
Last updated: February 20, 2007