Status:
UNKNOWN
Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)
Lead Sponsor:
Valley Retina Institute
Collaborating Sponsors:
Pfizer
Conditions:
Proliferative Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic Retinopathy (PDR) and reduce the need for retinal photocoagulation.
Detailed Description
Primary Objective: To further establish the efficacy of intravitreal pegaptanib injections in the regression of retinal neovascularization secondary to high-risk PDR, as compared to standard panretin...
Eligibility Criteria
Inclusion
- Eligible eyes will have active PDR with high risk characteristics (HRC) as defined by the DRS. All eyes must meet at least one or both of the following criteria:
- Mild neovascularization of the disc (NVD) of at least 1/4 to 1/3 disc area as shown in standard photograph 10A of the DRS.
- Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc area as shown in standard photograph 7 of the DRS.
- ETDRS visual acuity score greater than or equal to 24 letters (approximately 20/320) and less than or equal to 85 letters (approximately 20/20) by the ETDRS visual acuity protocol at the screening visit.
- Eyes with mild pre-retinal hemorrhage (PRH) or mild vitreous hemorrhage (VH) that does not interfere with clear visualization of the macula and optic disc are eligible for this study.
- Evaluating physician believes that PRP can be safely withheld for 3 weeks.
Exclusion
- Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc.
- Presence of either:
- significant epiretinal membranes involving the macula, OR
- proliferative diabetic membranes along the major retinal arcades that are extensive enough to cause either:
- significant vitreomacular traction, OR
- significant impairment in visual acuity.
- Presence of any tractional retinal detachment.
- Severe ischemia involving the foveal avascular zone as determined by fluorescein angiography performed at the initial screening visit.
- Significant media opacity (due to cornea, anterior chamber, or lens) precluding clear visualization of the macula or optic disc.
- Presence of neovascular glaucoma with or without hyphema.
- Previous treatment with intravitreal steroid injections in the study eye within 6 months of baseline.
- Previous treatment with peribulbar steroid injections in the study eye within 90 days of baseline
- Previous PRP laser treatment in the study eye within 90 days of baseline visit.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01486771
Start Date
November 1 2007
End Date
February 1 2014
Last Update
December 6 2011
Active Locations (1)
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1
Valley Retina Insitute, PA
McAllen, Texas, United States, 78503