TerminatedNot Applicable

Safety and Efficacy of Low-Fluence PRP for PDR

Stopped: Undefined

Mexico60 participantsStarted 2012-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Macular thickness change

Timeframe: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks

Trial details

NCT IDNCT01737957

SponsorAsociación para Evitar la Ceguera en México

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

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