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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Bhagat, Neelakshi, M.D., M.P.H.
ClinicalTrials.gov Identifier:
NCT01069341
First received: February 15, 2010
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention Phase
Rubeosis Iridis
Proliferative Diabetic Retinopathy
Drug: Ranibizumab
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab in Subjects With Dense Cataract and Rubeosis Due to Proliferative Diabetic Retinopathy (PDR)

Resource links provided by NLM:


Further study details as provided by Bhagat, Neelakshi, M.D., M.P.H.:

Primary Outcome Measures:
  • Adverse Event (AE) [ Time Frame: first 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA) [ Time Frame: months 3, 7 and 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: at month-12 ] [ Designated as safety issue: No ]
    Presence of proliferative diabetic retinopathy by fluorescein angiogram

  • Macular Volume [ Time Frame: at months-1,3,7, and 12 ] [ Designated as safety issue: No ]
    Macular volume (millimeters cubed [mm3]) by Stratus OCT

  • Mean Time to Re-treatment [ Time Frame: first 12 months ] [ Designated as safety issue: No ]
    Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)

  • Mean Number of Ranibizumab Injections [ Time Frame: first 12 months ] [ Designated as safety issue: No ]
    Mean number of ranibizumab injections required through month 12

  • Mean Number of PRP Laser Treatments [ Time Frame: first 12 months ] [ Designated as safety issue: No ]
    Mean number of PRP laser treatments required through month 12

  • Mean Change in Intraocular Pressure (IOP) [ Time Frame: at months-3,7, and 12 ] [ Designated as safety issue: No ]
    Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.


Enrollment: 4
Study Start Date: July 2007
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
All subjects enrolled received treatment with identical dosage of Ranibizumab
Drug: Ranibizumab
Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.
Other Name: Lucentis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069341

Locations
United States, New Jersey
Njms / Umdnj
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Bhagat, Neelakshi, M.D., M.P.H.
Genentech
Investigators
Principal Investigator: Neelakshi Bhagat, MD, MPH NJMS / UMDNJ
  More Information

No publications provided

Responsible Party: Bhagat, Neelakshi, M.D., M.P.H.
ClinicalTrials.gov Identifier: NCT01069341     History of Changes
Other Study ID Numbers: FVF 4297s
Study First Received: February 15, 2010
Results First Received: July 25, 2012
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bhagat, Neelakshi, M.D., M.P.H.:
Rubeosis
Neovascularization of iris
Proliferative diabetic retinopathy
PDR
Cataract

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Cataract
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lens Diseases

ClinicalTrials.gov processed this record on April 21, 2014