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
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 5, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedDecember 7, 2011
April 1, 2011
3 months
December 5, 2011
December 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.
7-14 days prior to surgical intervention
Secondary Outcomes (1)
Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs
7-14 days prior to surgical intervention
Study Arms (1)
Macugen (Pegaptanib Sodium)
EXPERIMENTALOpen-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
Interventions
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 Criteria
You may qualify if:
- Subjects of either gender aged 75 years or below diagnosed with tractional retinal detachment secondary to proliferative diabetic retinopathy.
You may not qualify if:
- Subjects with vitreous hemorrhage obscuring the posterior pole will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Retina Institute of Hawaii
Honolulu, Hawaii, 96815, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2011
First Posted
December 7, 2011
Study Start
April 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 7, 2011
Record last verified: 2011-04