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

NCT01486771 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-12-06

No results posted yet for this study

Summary

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

Conditions

  • Proliferative Diabetic Retinopathy

Interventions

DRUG

Macugen ® (pegaptanib sodium)

Patients assigned to either IV Mac Q6Arm will receive a total of 3 intravitreal pegaptanib sodium injections administered at 6-week intervals beginning on Day 0 and ending at Week 12. The group will then receive an intravitreal injection every 12 weeks. Patients assigned to IV Mac Q6Arm will receive a total of 3 intravitreal pegaptanib sodium injections administered at 6-week intervals beginning on Day 0 and ending at Week 12. After the third injection subjects in this group will receive Selective Laser Photocoagulation at Week 18. Patients assigned to Panretinal Photocoagulation will act as the control group. Subjects in this group will receive standard Panretinal Photocoagulation using a modified ETDRS protocol. All intravitreal study injections will consist of 0.3 milligrams (mg) of pegaptanib sodium delivered by intravitreal injection.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Valley Retina Institute

    lead OTHER

Principal Investigators

  • Victor H. Gonzalez, MD · Valley Retina Insitute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2013-08-31
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486771 on ClinicalTrials.gov