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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Retina Consultants of Houston
Houston, Texas, United States
Tractional Retinal Detachment Repair
Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
Time frame: 6 months
Post surgical interventions
Post surgical interventions including need for additional surgery, additional injections or PRP laser
Time frame: 6 Months
Vitreous Hemorrhage and Tractional Retinal Detachment Improvement
Pre and perioperative fundus photo comparisons on an objective scale
Time frame: 6 months
Adverse Events
Incidence and severity of ocular and nonocular adverse events, such as redetachment, progression to neovascular glaucoma, endophthalmitis, etc. through post operative month 3
Time frame: 6 months
Visual Acuity
Visual acuity as measured by BCVA
Time frame: 6 months
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