Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)

Status unconfirmed · Phase 4

Conditions studied: Proliferative Diabetic Retinopathy

In brief

Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic Retinopathy (PDR) and reduce the need for retinal photocoagulation.

Key facts

Study ID

NCT01486771

Run by

Valley Retina Institute

People needed

30

Starts

2007-11-01

Expected to finish

2014-02-01

Last updated by the study team

2011-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Valley Retina Insitute, PA — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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