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
Phase 1
Completed
- Conditions
- PDR
- Interventions
- Drug: Macugen (Pegaptanib Sodium)
- Registration Number
- NCT01487070
- Lead Sponsor
- Retina Institute of Hawaii
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Macugen (Pegaptanib Sodium) Macugen (Pegaptanib Sodium) Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
- Primary Outcome Measures
Name Time Method Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention. 7-14 days prior to surgical intervention
- Secondary Outcome Measures
Name Time Method Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs 7-14 days prior to surgical intervention
Trial Locations
- Locations (1)
Retina Institute of Hawaii
🇺🇸Honolulu, Hawaii, United States