Safety and Efficacy of Low-Fluence PRP for PDR

This study is currently recruiting participants.
Verified November 2012 by Asociación para Evitar la Ceguera en México
Sponsor:
Information provided by (Responsible Party):
Guillermo Salcedo-Villanueva, Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT01737957
First received: November 23, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Proliferative Diabetic Retinopathy
Device: Low-fluence PRP with 532nm green LASER
Device: Full-Fluence PRP with 532nm LASER

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Single-session, Low-fluence Panretinal Photocoagulation (PRP) for Proliferative Diabetic Retinopathy (PDR)

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Macular thickness change [ Time Frame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
    Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Presence or absence of adverse events


Other Outcome Measures:
  • Regression of neovessels, change over time [ Time Frame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Regression of neovessels observed by fluorescein angiography


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: PURE-POINT LASER

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737957

Locations
Mexico
Asociación Para Evitar la Ceguera en México Recruiting
Mexico City, DF, Mexico, 04030
Contact: Yoko Burgoa    (52) 55 10841400 ext 1172    yokoburgoa@yahoo.com   
Principal Investigator: Guillermo Salcedo-Villanueva, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Guillermo Salcedo-Villanueva, MD APEC
  More Information

No publications provided

Responsible Party: Guillermo Salcedo-Villanueva, MD, Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT01737957     History of Changes
Other Study ID Numbers: APEC-LFPRP
Study First Received: November 23, 2012
Last Updated: November 28, 2012
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Asociación para Evitar la Ceguera en México:
Proliferative Diabetic retinopathy
Pan-retinal photocoagulation

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014