PDR
Conditions
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.
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.
Sponsors
Retina Institute of Hawaii
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention. | 7-14 days prior to surgical intervention |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs | 7-14 days prior to surgical intervention |
Countries
United States
Outcome results
None listed