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

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069341
• Other study ID #: FVF 4297s
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2010
• Last updated: September 4, 2012
• Start date: July 2007
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Bhagat, Neelakshi, M.D., M.P.H.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Rubeosis Iridis

Intervention

Drug:
• Ranibizumab
Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.

Locations

Country	Name	City	State
United States	Njms / Umdnj	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Bhagat, Neelakshi, M.D., M.P.H.	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event (AE)	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	Yes
Secondary	Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)	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	No
Secondary	Presence of Proliferative Diabetic Retinopathy (PDR)	Presence of proliferative diabetic retinopathy by fluorescein angiogram	at month-12	No
Secondary	Macular Volume	Macular volume (millimeters cubed [mm3]) by Stratus OCT	at months-1,3,7, and 12	No
Secondary	Mean Time to Re-treatment	Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)	first 12 months	No
Secondary	Mean Number of Ranibizumab Injections	Mean number of ranibizumab injections required through month 12	first 12 months	No
Secondary	Mean Number of PRP Laser Treatments	Mean number of PRP laser treatments required through month 12	first 12 months	No
Secondary	Mean Change in Intraocular Pressure (IOP)	Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.	at months-3,7, and 12	No