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

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ClinicalTrials.gov Identifier: NCT01069341
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Bhagat, Neelakshi, M.D., M.P.H.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Rubeosis Iridis Proliferative Diabetic Retinopathy Drug: Ranibizumab Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ranibizumab in Subjects With Dense Cataract and Rubeosis Due to Proliferative Diabetic Retinopathy (PDR)
Study Start Date : July 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. Presence of Proliferative Diabetic Retinopathy (PDR) [ Time Frame: at month-12 ]
    Presence of proliferative diabetic retinopathy by fluorescein angiogram

  3. Macular Volume [ Time Frame: at months-1,3,7, and 12 ]
    Macular volume (millimeters cubed [mm3]) by Stratus OCT

  4. 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)

  5. Mean Number of Ranibizumab Injections [ Time Frame: first 12 months ]
    Mean number of ranibizumab injections required through month 12

  6. Mean Number of PRP Laser Treatments [ Time Frame: first 12 months ]
    Mean number of PRP laser treatments required through month 12

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069341


Locations
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United States, New Jersey
Njms / Umdnj
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Bhagat, Neelakshi, M.D., M.P.H.
Genentech, Inc.
Investigators
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Principal Investigator: Neelakshi Bhagat, MD, MPH NJMS / UMDNJ
More Information
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Responsible Party: Bhagat, Neelakshi, M.D., M.P.H.
ClinicalTrials.gov Identifier: NCT01069341    
Other Study ID Numbers: FVF 4297s
First Posted: February 17, 2010    Key Record Dates
Results First Posted: October 4, 2012
Last Update Posted: October 4, 2012
Last Verified: September 2012
Keywords provided by Bhagat, Neelakshi, M.D., M.P.H.:
Rubeosis
Neovascularization of iris
Proliferative diabetic retinopathy
PDR
Cataract
Additional relevant MeSH terms:
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Cataract
Retinal Diseases
Diabetic Retinopathy
Lens Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents