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

Phase 1

Completed

• Conditions: Rubeosis Iridis; Proliferative Diabetic Retinopathy
• Interventions: Drug: Ranibizumab

• Registration Number: NCT01069341
• Lead Sponsor: Bhagat, Neelakshi, M.D., M.P.H.

Brief Summary

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

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Results First Submitted: 2012-07-25
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-04
• Last Update Submitted: 2012-09-04
• Results First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Ranibizumab	All subjects enrolled received treatment with identical dosage of Ranibizumab

Primary Outcome Measures

Name	Time	Method
Adverse Event (AE)	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Njms / Umdnj; 🇺🇸 Newark, New Jersey, United States