Phase 1
N=4
Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery
Rubeosis Iridis · Proliferative Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT01069341 ↗Enrolled (actual)
4
Serious AEs
75.0%
Results posted
Oct 2012
Primary outcome: Primary: Adverse Event (AE) — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ranibizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bhagat, Neelakshi, M.D., M.P.H.
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Event (AE) |
— | — |
| SECONDARY Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA) |
0; 0; 0 | — |
| SECONDARY Presence of Proliferative Diabetic Retinopathy (PDR) |
— | — |
| SECONDARY Macular Volume |
7.47; 6.94; 6.40; 6.64 | — |
| SECONDARY Mean Time to Re-treatment |
1 | — |
| SECONDARY Mean Number of Ranibizumab Injections |
3.5 | — |
| SECONDARY Mean Number of PRP Laser Treatments |
0.5 | — |
| SECONDARY Mean Change in Intraocular Pressure (IOP) |
0; 1; 0 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01069341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.