Safety and Efficacy of Low-Fluence PRP for PDR

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014