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Prospective, Randomized, Open Label, Phase II Study to Assess Efficacy and Safety of Macugen® (Pegaptanib 0.3 mg Intravitreal Injections) Plus Panretinal Photocoagulation and PRP (Monotherapy) in the Treatment With High Risk PDR.

NCT01281098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-03-19

No results posted yet for this study

Summary

To evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy (pegaptanib 0.3 mg plus PRP) in patients with Type I or Type II diabetes mellitus and with high risk proliferative diabetic retinopathy.

Conditions

  • High Risk Proliferative Diabetic Retinopathy
  • Diabetes Mellitus Type I
  • Diabetes Mellitus Type II

Interventions

PROCEDURE

Panretinal Photocoagulation (PRP)

Panretinal Photocoagulation (PRP)

DRUG

Intravitreous injection of pegaptanib

Intravitreous injection of pegaptanib

Sponsors & Collaborators

  • Association for Innovation and Biomedical Research on Light and Image

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-10-31
Completion
2013-02-28

Countries

  • Portugal

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 NCT01281098 on ClinicalTrials.gov