Retrospective Review of Proliferative Diabetic Retinopathy Patients

Status unconfirmed

Conditions studied: Proliferative Diabetic Retinopathy

In brief

The primary objective of the protocol is to determine if intravitreal ranibizumab alone decreases retinal neovascularization from Proliferative Diabetic Retinopathy (PDR) with deferred panretinal photocoagulation (PRP) and/or vitrectomy at one year after treatment with ranibizumab has been initiated.

Key facts

Study ID

NCT03609996

Run by

Elman Retina Group

People needed

100

Starts

2018-06-01

Expected to finish

2019-12-01

Last updated by the study team

2019-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years Individuals <18 years old are not being included because PDR is so rare in this age group that the diagnosis of PDR may be questionable.
• Diagnosis of diabetes mellitus (type 1 or type 2)
• Any one of the following will be considered to be sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes
• Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
• Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions
• Presence of PDR which the investigator has treated the study eye(s) with ranibizumab

You may not qualify if…

• History of prior panretinal photocoagulation prior to initiating ranibizumab
• Tractional retinal detachment involving the macula.
• A tractional retinal detachment is not an exclusion if it is outside of the posterior pole (not threatening the macula)
• History of vitrectomy prior to initiating ranibizumab
• Treatment with Ranibizumab within six months of treatment regimen

Where it is running

• Elman Retina Group — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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