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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Pilot Study to Determine if Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 12 Weeks for a Year After an Induction Phase of Three Injections Every 6 Weeks Will Reduce the Progress

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

Detailed Summary:

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 panretinal photocoagulation (PRP)

Secondary Objective:

To maintain the regression of PDR after the induction phase with intravitreal pegaptanib injections administered at 12-week intervals, as compared to standard PRP

To maintain the regression of PDR after the induction phase with retinal photocoagulation applied to areas of ischemia (Selective Laser Photocoagulation), as compared to standard PRP

To evaluate the rate of recurrence of neovascularization after 6 intravitreal pegaptanib injections

To determine if intravitreal pegaptanib will reduce the area and/or volume of concomitant diabetic macular edema, as assessed by leakage on fluorescein angiography (FA) and/or optical coherence tomography (OCT)

To determine if intravitreal pegaptanib injections maintain or reduce the loss of best-corrected visual acuity


Sponsor: Valley Retina Institute

Current Primary Outcome: Establish efficacy of intravitreal pegaptanib sodium injections in causing regression of high risk proliferative diabetic retinopathy as compared to panretinal photocoagulation [ Time Frame: 54 weeks ]

To assess the efficacy of intravitreal pegaptanib sodium injections in inducing regression of high risk PDR (as determined by percentage of eyes without treatment failure) using standard panretinal photocoagulation (PRP) as the control arm. Treatment failure is defined as:

  • Development of increased NVD and/or NVE
  • NVD and/or NVE that is not regressed at least 50% compared to the baseline amount within 3 weeks
  • Development of significant vitreous hemorrhage that is sufficient in quantity to obscure visualization of the entire macula, optic disc, and the major temporal arcade vessels


Original Primary Outcome: Same as current

Current Secondary Outcome: Establish the efficacy of intravitreal pegaptanib injections in preventing the loss of best corrected visual acuity [ Time Frame: 54 weeks ]

To determine if intravitreal pegaptanib sodium injections maintain or reduce the loss of best-corrected visual acuity as measured by comparing the percentages of patients that lost 3 or more lines on ETDRS chart in the study arms.


Original Secondary Outcome: To assess the efficacy of intravitreal pegaptanib injections in preventing the loss of best corrected visual acuity [ Time Frame: 54 weeks ]

To determine if intravitreal pegaptanib sodium injections maintain or reduce the loss of best-corrected visual acuity as measured by comparing the percentages of patients that lost 3 or more lines on ETDRS chart in the study arms.


Information By: Valley Retina Institute

Dates:
Date Received: December 2, 2011
Date Started: November 2007
Date Completion: February 2014
Last Updated: December 5, 2011
Last Verified: December 2011