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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
PDR |
Drug: Macugen (Pegaptanib Sodium) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention. [ Time Frame: 7-14 days prior to surgical intervention ] [ Designated as safety issue: Yes ]
- Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs [ Time Frame: 7-14 days prior to surgical intervention ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | April 2011 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Macugen (Pegaptanib Sodium)
Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
|
Drug: Macugen (Pegaptanib Sodium)
Pegaptanib sodium drug substance is a pegylated (40 kDa branched PEG molecule consisting of two 20 kDa PEG arms) anti-VEGF aptamer. It is formulated in phosphate buffered saline at pH 6-7. Sodium hydroxide or hydrochloric acid may be added for pH adjustment. Pegaptanib sodium is formulated at 0.3mg/90µl and presented in a USP Type I glass barrel syringe sealed with a bromobutyl rubber stopper. A 30-guage needle is fixed to the end of the syringe after removal of the rubber stopper. The syringe comes in a sealed foil pouch, and the 30-gauge needle is added to the sterile injection field separately. The drug product is preservative-free and intended for single use by intravitreous injection only. |
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Retina Institute of Hawaii |
| ClinicalTrials.gov Identifier: | NCT01487070 History of Changes |
| Other Study ID Numbers: | RIH1005 |
| Study First Received: | December 5, 2011 |
| Last Updated: | December 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Detachment Retinal Diseases Eye Diseases Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013