Back to resultsA 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
Primary Purpose
PDR
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Macugen (Pegaptanib Sodium)
Sponsored by
About this trial
This is an interventional treatment trial for PDR
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.
Sites / Locations
- Retina Institute of Hawaii
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Macugen (Pegaptanib Sodium)
Arm Description
Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
Outcomes
Primary Outcome Measures
Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.
Secondary Outcome Measures
Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs
Full Information
NCT ID
NCT01487070
First Posted
December 5, 2011
Last Updated
December 5, 2011
Sponsor
Retina Institute of Hawaii
1. Study Identification
Unique Protocol Identification Number
NCT01487070
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Retina Institute of Hawaii
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PDR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macugen (Pegaptanib Sodium)
Arm Type
Experimental
Arm Description
Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
Intervention Type
Drug
Intervention Name(s)
Macugen (Pegaptanib Sodium)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.
Time Frame
7-14 days prior to surgical intervention
Secondary Outcome Measure Information:
Title
Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs
Time Frame
7-14 days prior to surgical intervention
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Retina Institute of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96815
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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