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

• 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.

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).

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.

• Rubeosis Iridis
• Proliferative Diabetic Retinopathy

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