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

September 4, 2012 updated by: Bhagat, Neelakshi, M.D., M.P.H.

Ranibizumab in Subjects With Dense Cataract and Rubeosis Due to Proliferative Diabetic Retinopathy (PDR)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Njms / Umdnj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment
All subjects enrolled received treatment with identical dosage of Ranibizumab
Drug: Ranibizumab
Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event (AE)
Time Frame: first 12 months
Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).
first 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)
Time Frame: months 3, 7 and 12
Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12
months 3, 7 and 12
Presence of Proliferative Diabetic Retinopathy (PDR)
Time Frame: at month-12
Presence of proliferative diabetic retinopathy by fluorescein angiogram
at month-12
Macular Volume
Time Frame: at months-1,3,7, and 12
Macular volume (millimeters cubed [mm3]) by Stratus OCT
at months-1,3,7, and 12
Mean Time to Re-treatment
Time Frame: first 12 months
Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)
first 12 months
Mean Number of Ranibizumab Injections
Time Frame: first 12 months
Mean number of ranibizumab injections required through month 12
first 12 months
Mean Number of PRP Laser Treatments
Time Frame: first 12 months
Mean number of PRP laser treatments required through month 12
first 12 months
Mean Change in Intraocular Pressure (IOP)
Time Frame: at months-3,7, and 12
Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.
at months-3,7, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Neelakshi Bhagat, MD, MPH, Njms / Umdnj

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 15, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVF 4297s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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