MedDataX Logo

Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery

NCT ID: NCT01069341

Last Updated: 2012-10-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in diabetic subjects presenting initially with dense cataract and proliferative diabetic retinopathy induced rubeosis. Ten subjects will be enrolled at a single center over a 10 month period. Patients will be followed for a total of 12 months in the treatment phase and will have safety follow-ups at Months 18 and 24. Eligibility for study entry will be determined by the principal investigator.

Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every month for 3 doses (loading dose on Day 0 and at Months 1 and 2) followed by as needed re-treatment based on specified criteria for the remainder of the study period. Subjects can receive a maximum of eight injections of ranibizumab during the study. All subjects will undergo cataract surgery after the first ranibizumab injection. Only one eye will be designated as the study eye for the duration of the study to receive the ranibizumab injections.

All subjects will be evaluated with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, intraocular pressure measurement, ophthalmological examination, slit lamp photography, gonioscopy, fundus photography, fundus fluorescein angiography and Optical Coherence Tomography (OCT). An ultrasound will be done as needed. Best corrected ETDRS visual acuity and intraocular pressure measurements will be performed on both eyes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rubeosis Iridis Proliferative Diabetic Retinopathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Rubeosis Neovascularization of iris Proliferative diabetic retinopathy PDR Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

All subjects enrolled received treatment with identical dosage of Ranibizumab

Group Type OTHER

Ranibizumab

Intervention Type DRUG

Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ranibizumab

Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lucentis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 years or over
* Subjects with diabetes mellitus
* Subjects with proliferative diabetic retinopathy induced rubeosis
* Be willing to undergo cataract surgery
* HgbA1c level \< 12%

Exclusion Criteria

* History of glaucoma surgery
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
* Intraocular surgery in the study eye within 60 days preceding Day 0
* History of prior pars plana vitrectomy in the study eye
* Positive pregnancy test
* HbA1c \>12
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Bhagat, Neelakshi, M.D., M.P.H.

INDIV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Neelakshi Bhagat, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

NJMS / UMDNJ

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Njms / Umdnj

Newark, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FVF 4297s

Identifier Type: -

Identifier Source: org_study_id