Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery
|ClinicalTrials.gov Identifier: NCT01069341|
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Rubeosis Iridis Proliferative Diabetic Retinopathy||Drug: Ranibizumab||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
All subjects enrolled received treatment with identical dosage of Ranibizumab
Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.
Other Name: Lucentis
- 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).
- 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
- Presence of Proliferative Diabetic Retinopathy (PDR) [ Time Frame: at month-12 ]Presence of proliferative diabetic retinopathy by fluorescein angiogram
- Macular Volume [ Time Frame: at months-1,3,7, and 12 ]Macular volume (millimeters cubed [mm3]) by Stratus OCT
- 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)
- Mean Number of Ranibizumab Injections [ Time Frame: first 12 months ]Mean number of ranibizumab injections required through month 12
- Mean Number of PRP Laser Treatments [ Time Frame: first 12 months ]Mean number of PRP laser treatments required through month 12
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069341
|United States, New Jersey|
|Njms / Umdnj|
|Newark, New Jersey, United States, 07103|
|Principal Investigator:||Neelakshi Bhagat, MD, MPH||NJMS / UMDNJ|