NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Retrospective Review of Proliferative Diabetic Retinopathy Patients

UnknownN/A

Sponsor: Elman Retina Group

Conditions: Proliferative Diabetic Retinopathy

Interventions: Panretinal Photocoagulation, Lucentis

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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
3. Presence of PDR which the investigator has treated the study eye(s) with ranibizumab

Exclusion Criteria:

1. History of prior panretinal photocoagulation prior to initiating ranibizumab
2. 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)
3. History of vitrectomy prior to initiating ranibizumab
4. Treatment with Ranibizumab within six months of treatment regimen

Locations (1)

Baltimore, Maryland, United States