Clinical Trial: Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study

Brief Summary: Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic Macular Edema (DME), as compared to injections every 6 weeks.

Detailed Summary:

This is a 24 week clinical study which will be double-masked. Subjects will be randomly assigned 2:1 to Macugen® every 4 weeks (IVMac q4 arm) or Macugen® every 6 weeks (IVMac q6 arm). If both eyes are eligible, then one eye will be randomized into the trial. Fellow eyes of patients with two eligible eyes will be monitored and treated with standard clinical care. If sufficient fellow eyes are treated, this will provide an internal control group for direct comparison of the Macugen® treated study eyes versus the fellow eyes. Both study eyes and fellow eyes will be assessed in the same fashion at every time point during this study.

Each site is to have at least one Unmasked investigator to perform the study injections and one Masked investigator to perform study evaluations and assess adverse events. Roles cannot be reversed after study treatment for a given subject has begun.

Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6 week intervals beginning on Day 0 and ending at Week 18. Each Macugen® injection will be administered as described in the package insert.


Sponsor: Valley Retina Institute

Current Primary Outcome: Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline. [ Time Frame: 24 weeks ]

The primary efficacy outcome measure is the proportion of subjects who gain two or more lines in BCVA score in the Study Eye compared with baseline at 24 weeks. The BCVA is to be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.


Original Primary Outcome: Proportion of subjects who gain two or more lines in Best Corrected Visual Acuity(BCVA) score compared with baseline. [ Time Frame: 24 weeks ]

The primary efficacy outcome measure is the proportion of subjects who gain two or more lines in BCVA score compared with baseline at 24 weeks


Current Secondary Outcome:

  • Mean Change From Baseline at Week 24 in Central Foveal Thickness [ Time Frame: 24 Weeks ]
    Optical Coherence Tomography (OCT) will be used to assess the central foveal thickness of each patient. The mean change from baseline to week 24 will be calculated for each patient.
  • Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24. [ Time Frame: 24 weeks ]

    There is a possibility that some subjects may not respond to the study treatment to which they have been assigned. Macular laser treatment is considered an alternative treatment for retinal edema. A lower proportion of subjects requiring macular laser treatment would indicate a superior treatment regimen.

    This will be assessed at week 12, and again at week 24.



Original Secondary Outcome:

  • Mean change from baseline to week 24 in central foveal thickness as assessed on Optical Coherence Tomography (OCT). [ Time Frame: 24 Weeks ]
    Mean change from baseline to week 24 in central foveal thickness as assessed on OCT.
  • Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24. [ Time Frame: 24 weeks ]
    Proportion of subjects requiring macular laser treatment at week 12 and week 24.


Information By: Valley Retina Institute

Dates:
Date Received: December 2, 2011
Date Started: April 2009
Date Completion:
Last Updated: June 12, 2013
Last Verified: June 2013