Safety and Efficacy of Low-Fluence PRP for PDR

NCT ID: NCT01737957

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low-fluence

Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy

Group Type EXPERIMENTAL

Low-fluence PRP with 532nm green LASER

Intervention Type DEVICE

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

Full-fluence

Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy

Group Type ACTIVE_COMPARATOR

Full-Fluence PRP with 532nm LASER

Intervention Type DEVICE

To administer full-fluence PRP in two sessions for PDR

Interventions

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Low-fluence PRP with 532nm green LASER

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

Intervention Type DEVICE

Full-Fluence PRP with 532nm LASER

To administer full-fluence PRP in two sessions for PDR

Intervention Type DEVICE

Other Intervention Names

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PURE-POINT LASER PURE-POINT LASER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillermo Salcedo-Villanueva, MD

Role: PRINCIPAL_INVESTIGATOR

Asociación para Evitar la Ceguera en México

Locations

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Asociación Para Evitar la Ceguera en México

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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APEC-LFPRP

Identifier Type: -

Identifier Source: org_study_id

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