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Safety and Efficacy of Low-Fluence PRP for PDR

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Low-fluence PRP with 532nm green LASER
Full-Fluence PRP with 532nm LASER
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative Diabetic retinopathy, Pan-retinal photocoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asociación Para Evitar la Ceguera en MéxicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-fluence

Full-fluence

Arm Description

Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy

Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy

Outcomes

Primary Outcome Measures

Macular thickness change
Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)

Secondary Outcome Measures

Adverse events
Presence or absence of adverse events

Full Information

First Posted
November 23, 2012
Last Updated
November 28, 2012
Sponsor
Asociación para Evitar la Ceguera en México
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1. Study Identification

Unique Protocol Identification Number
NCT01737957
Brief Title
Safety and Efficacy of Low-Fluence PRP for PDR
Official Title
Safety and Efficacy of Single-session, Low-fluence Panretinal Photocoagulation (PRP) for Proliferative Diabetic Retinopathy (PDR)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Proliferative Diabetic retinopathy, Pan-retinal photocoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-fluence
Arm Type
Experimental
Arm Description
Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy
Arm Title
Full-fluence
Arm Type
Active Comparator
Arm Description
Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy
Intervention Type
Device
Intervention Name(s)
Low-fluence PRP with 532nm green LASER
Other Intervention Name(s)
PURE-POINT LASER
Intervention Description
To administer low-fluence PRP in a single session for PDR
Intervention Type
Device
Intervention Name(s)
Full-Fluence PRP with 532nm LASER
Other Intervention Name(s)
PURE-POINT LASER
Intervention Description
To administer full-fluence PRP in two sessions for PDR
Primary Outcome Measure Information:
Title
Macular thickness change
Description
Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)
Time Frame
Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
Presence or absence of adverse events
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Regression of neovessels, change over time
Description
Regression of neovessels observed by fluorescein angiography
Time Frame
Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Salcedo-Villanueva, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación Para Evitar la Ceguera en México
City
Mexico City
State/Province
DF
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoko Burgoa
Phone
(52) 55 10841400
Ext
1172
Email
yokoburgoa@yahoo.com
First Name & Middle Initial & Last Name & Degree
Guillermo Salcedo-Villanueva, MD

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Low-Fluence PRP for PDR

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