Safety and Efficacy of Low-Fluence PRP for PDR

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01737957

Enrollment

Registered

2012-11-30

Start date

2012-11-30

Completion date

2013-03-31

Last updated

2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic retinopathy, Pan-retinal photocoagulation

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.

Interventions

DEVICELow-fluence PRP with 532nm green LASER

To administer low-fluence PRP in a single session for PDR

DEVICEFull-Fluence PRP with 532nm LASER

To administer full-fluence PRP in two sessions for PDR

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Macular thickness change	Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks	Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)

Secondary

Measure	Time frame	Description
Adverse events	16 weeks	Presence or absence of adverse events

Other

Measure	Time frame	Description
Regression of neovessels, change over time	Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks	Regression of neovessels observed by fluorescein angiography

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026