Safety and Efficacy of Low-Fluence PRP for PDR

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01737957
• Other study ID #: APEC-LFPRP
• Status: Terminated
• Phase: N/A
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• Low-fluence PRP with 532nm green LASER
To administer low-fluence PRP in a single session for PDR
• Full-Fluence PRP with 532nm LASER
To administer full-fluence PRP in two sessions for PDR

Locations

Country	Name	City	State
Mexico	Asociación Para Evitar la Ceguera en México	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Regression of neovessels, change over time	Regression of neovessels observed by fluorescein angiography	Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Primary	Macular thickness change	Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)	Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Secondary	Adverse events	Presence or absence of adverse events	16 weeks