A Study of the Safety, Tolerability, and Efficacy of IVT Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy (No-Crunch01)
The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized 1:1, Masked, Study of the Safety, Tolerability, and Efficacy of Intravitreal Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Adjuvant Management of TRD and Vit Hem Associated With PDR|
- Tractional Retinal Detachment Repair [ Time Frame: 6 months ] [ Designated as safety issue: No ]Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
- Post surgical interventions [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Post surgical interventions including need for additional surgery, additional injections or PRP laser
- Vitreous Hemorrhage and Tractional Retinal Detachment Improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]Pre and perioperative fundus photo comparisons on an objective scale
- Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Incidence and severity of ocular and nonocular adverse events, such as redetachment, progression to neovascular glaucoma, endophthalmitis, etc. through post operative month 3
- Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]Visual acuity as measured by BCVA
|Study Start Date:||April 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: 0.3mg Pegaptanib Sodium, Macugen
will receive Macugen intravitreal injection prior to surgery
one intravitreal injection of Macugen prior to vitrectomy surgery
Other Name: 0.3mg Pegaptanib Sodium, Macugen
Sham Comparator: Sham injection
will receive a sham injection
The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.
Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 0.3mg Macugen™ prior to surgery versus sham injection.
Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery.
Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule.
Some photos may be limited secondary to vitreous hemorrhage. Follow up visits after surgery will be one day, one week, one month, and three months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589718
|United States, Texas|
|Retina Consultants of Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James C Major, MD||PI|