A Single-Center Trial of Intravitreous Injections of Macugen (Pegaptanib Sodium) Given at Least 7 Days Before Vitrectomy Secondary To Tractional Retinal Detachment in Proliferative Diabetic Retinopathy
Overview
- Phase
- Phase 1
- Intervention
- Macugen (Pegaptanib Sodium)
- Conditions
- PDR
- Sponsor
- Retina Institute of Hawaii
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Primary objective of this trial will be to evaluate the safety and efficacy of intravitreal injections of Macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy in subjects with tractional retinal detachment (with or withoutmacular involvement) secondary to proliferative diabetic retinopathy.
Secondary objective is to evaluate regression of neovascularization and progression of macular traction utilizing OCT and fundus photographs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects of either gender aged 75 years or below diagnosed with tractional retinal detachment secondary to proliferative diabetic retinopathy.
Exclusion Criteria
- •Subjects with vitreous hemorrhage obscuring the posterior pole will be excluded.
Arms & Interventions
Macugen (Pegaptanib Sodium)
Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
Intervention: Macugen (Pegaptanib Sodium)
Outcomes
Primary Outcomes
Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.
Time Frame: 7-14 days prior to surgical intervention
Secondary Outcomes
- Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs(7-14 days prior to surgical intervention)