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
|ClinicalTrials.gov Identifier: NCT01487070|
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : December 7, 2011
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 or disease||Intervention/treatment||Phase|
|PDR||Drug: Macugen (Pegaptanib Sodium)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2011|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
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.
- Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention. [ Time Frame: 7-14 days prior to surgical intervention ]
- Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs [ Time Frame: 7-14 days prior to surgical intervention ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487070
|United States, Hawaii|
|Retina Institute of Hawaii|
|Honolulu, Hawaii, United States, 96815|