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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01589718|
Recruitment Status : Withdrawn (No patients were enrolled)
First Posted : May 2, 2012
Last Update Posted : March 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Proliferative Diabetic Retinopathy||Drug: Macugen Drug: Sham||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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.
- Tractional Retinal Detachment Repair [ Time Frame: 6 months ]Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
- Post surgical interventions [ Time Frame: 6 Months ]Post surgical interventions including need for additional surgery, additional injections or PRP laser
- Vitreous Hemorrhage and Tractional Retinal Detachment Improvement [ Time Frame: 6 months ]Pre and perioperative fundus photo comparisons on an objective scale
- Adverse Events [ Time Frame: 6 months ]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 ]Visual acuity as measured by BCVA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589718
|United States, Texas|
|Retina Consultants of Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James C Major, MD||PI|