Safety and Efficacy of Low-Fluence PRP for PDR

November 28, 2012 updated by: Guillermo Salcedo-Villanueva, Asociación para Evitar la Ceguera en México

Safety and Efficacy of Single-session, Low-fluence Panretinal Photocoagulation (PRP) for Proliferative Diabetic Retinopathy (PDR)

To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico City, DF, Mexico, 04030
        • Recruiting
        • Asociación Para Evitar la Ceguera en México
        • Contact:
        • Principal Investigator:
          • Guillermo Salcedo-Villanueva, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 or type 2 diabetics
  • Proliferative diabetic retinopathy

Exclusion Criteria:

  • Previous treatment with PRP
  • Media opacities
  • Previous treatment for macular edema (LASER or intravitreal injections)
  • Recent (less than 6 months) ophthalmic surgery
  • Only eyes
  • Intra-retinal or sub-retinal fluid with foveal involvement
  • Chronic renal failure
  • History of liver or pancreatic transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-fluence
Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy
Device: Low-fluence PRP with 532nm green LASER
To administer low-fluence PRP in a single session for PDR
Other Names:
  • PURE-POINT LASER
Active Comparator: Full-fluence
Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy
Device: Full-Fluence PRP with 532nm LASER
To administer full-fluence PRP in two sessions for PDR
Other Names:
  • PURE-POINT LASER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular thickness change
Time Frame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)
Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 16 weeks
Presence or absence of adverse events
16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression of neovessels, change over time
Time Frame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Regression of neovessels observed by fluorescein angiography
Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Principal Investigator: Guillermo Salcedo-Villanueva, MD, Asociación Para Evitar la Ceguera en México

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

November 23, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-LFPRP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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