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
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | April 2012 |
| End Date: | December 2014 |
| Contact: | James C Major, MD |
| Email: | jcmmd@houstonretina.com |
| Phone: | 713-524-3434 |
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
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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