Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
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Purpose
In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE
| Condition | Intervention | Phase |
|---|---|---|
|
Retinal Disease |
Drug: Avastin (Bevacizumab) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial |
- Best corrected visual acuity [ Time Frame: At 12 week ] [ Designated as safety issue: Yes ]
- Macular thickness by OCT [ Time Frame: At 12 week ] [ Designated as safety issue: Yes ]
- Need for macular photocuagulation [ Time Frame: At 12th week ] [ Designated as safety issue: Yes ]
- Incidence of new vessel formation [ Time Frame: At 12th week ] [ Designated as safety issue: Yes ]
| Enrollment: | 82 |
| Study Start Date: | August 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Intravitreal injection of Avastin
|
Drug: Avastin (Bevacizumab)
Intravitreal injection of 125 mg Avastin
|
| Sham Comparator: 2 |
Drug: Avastin (Bevacizumab)
Intravitreal injection of 125 mg Avastin
|
Detailed Description:
After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with acute BRVO with less than three month duration
Exclusion Criteria:
- vision less than 20/320 and vison more than 20/50
- duration more than 3 months
- history of glaucoma and diabetic retinopathy
- any media opacity that prevent funduscopy
Contacts and Locations| Iran, Islamic Republic of | |
| Siamak Moradian, MD | |
| Tehran, Iran, Islamic Republic of, 16666 | |
| Principal Investigator: | Siamak Moradian, MD | Ophthalmic Research Center of Shaheed Beheshti Medical University |
More Information
No publications provided by Shaheed Beheshti Medical University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00370851 History of Changes |
| Other Study ID Numbers: | 8532 |
| Study First Received: | August 31, 2006 |
| Last Updated: | November 23, 2009 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Shaheed Beheshti Medical University:
|
intravitreal Avastin BRVO Macular edema |
Additional relevant MeSH terms:
|
Retinal Diseases Eye Diseases Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013