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
- Registration Number
- NCT01589718
- Lead Sponsor
- Greater Houston Retina Research
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Best corrected visual acuity in the study eye between 20/30 and light perception (LP)
- Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Age ≥ 18 years
- For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study
- History of anti-VEGF treatment in the study eye
- History of previous pars plana vitrectomy in the study eye
- Intraocular surgery in the study eye within one month of the study
- Patients with extensive vitreous hemorrhage in conjunction with a rhegmatogenous retinal detachment
- Tractional retinal detachment from causes inconsistent with PDR, such as inflammation or trauma
- Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or if allowed to progress untreated could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the study period.
- Active intraocular inflammation (grade trace or above) in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Uncontrolled glaucoma in the study eye (defined as IOP≥ 35 mmHg despite treatment with anti-glaucoma medication)
- History of glaucoma-filtering surgery in the study eye
- History of corneal transplant in the study eye
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sham injection Sham will receive a sham injection 0.3mg Pegaptanib Sodium, Macugen Macugen will receive Macugen intravitreal injection prior to surgery
- Primary Outcome Measures
Name Time Method Tractional Retinal Detachment Repair 6 months Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
- Secondary Outcome Measures
Name Time Method Adverse Events 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 6 months Visual acuity as measured by BCVA
Post surgical interventions 6 Months Post surgical interventions including need for additional surgery, additional injections or PRP laser
Vitreous Hemorrhage and Tractional Retinal Detachment Improvement 6 months Pre and perioperative fundus photo comparisons on an objective scale
Trial Locations
- Locations (1)
Retina Consultants of Houston
🇺🇸Houston, Texas, United States