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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rubeosis Iridis, Proliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>All subjects enrolled received treatment with identical dosage of Ranibizumab | Drug: Ranibizumab<br>* Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Presence of Proliferative Diabetic Retinopathy (PDR) | Presence of proliferative diabetic retinopathy by fluorescein angiogram | at month-12 | 
| Macular Volume | Macular volume (millimeters cubed [mm3]) by Stratus OCT | at months-1,3,7, and 12 | 
| Mean Time to Re-treatment | Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months) | first 12 months | 
| Mean Number of Ranibizumab Injections | Mean number of ranibizumab injections required through month 12 | first 12 months | 
| Mean Number of PRP Laser Treatments | Mean number of PRP laser treatments required through month 12 | first 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDR, Rubeosis, Neovascularization of iris, Proliferative diabetic retinopathy, Cataract