Retrospective Review of Proliferative Diabetic Retinopathy Patients

NCT03609996 | Unknown FDA Drug FDA Device

• 1 other identifier: ML29652
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Clinical regression of neovascularization not requiring further treatment beyond RBZ

  Clinical regression of neovascularization not requiring further treatment beyond RBZ

  2009-2018

Study Arms (2)

PDR treated with Laser

Device: Panretinal Photocoagulation; Drug: Lucentis

PDR treated with Lucentis

Device: Panretinal Photocoagulation; Drug: Lucentis

Interventions

Panretinal Photocoagulation DEVICE

Laser treatment for PDR

PDR treated with Laser; PDR treated with Lucentis

Lucentis DRUG

Intraviteral injection

PDR treated with Laser; PDR treated with Lucentis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 160 eyes that have been diagnosed with PDR that have been treated with ranibizumab will be looked at retrospectively.

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.
• History of vitrectomy prior to initiating ranibizumab
• Treatment with Ranibizumab within six months of treatment regimen

Sponsors & Collaborators

• Elman Retina Group: lead
• Roche-Genentech: collaborator

Study Sites (1)

Elman Retina Group

Baltimore, Maryland, 21237, United States

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael Elman

  Elman Retina Group, P.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

US (1)