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Safety and Efficacy of Low-Fluence PRP for PDR

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Guillermo Salcedo-Villanueva, Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737957
First Posted: November 30, 2012
Last Update Posted: November 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Guillermo Salcedo-Villanueva, Asociación para Evitar la Ceguera en México
  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
Intervention Model: Single Group Assignment
Masking: Single (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 Guillermo Salcedo-Villanueva, 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 ]
    Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 16 weeks ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 23, 2012
First Posted: November 30, 2012
Last Update Posted: November 30, 2012
Last Verified: November 2012

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

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