Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01069341
Study type Interventional
Source Bhagat, Neelakshi, M.D., M.P.H.
Contact
Status Completed
Phase Phase 1
Start date July 2007
Completion date January 2012

See also
  Status Clinical Trial Phase
Recruiting NCT01921192 - Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy Phase 4
Recruiting NCT01044875 - Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy N/A
Active, not recruiting NCT00993525 - Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study) Phase 1/Phase 2
Completed NCT01307072 - Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy N/A
Completed NCT01758757 - Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy N/A
Withdrawn NCT00600236 - HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population Phase 3
Completed NCT05414149 - Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy N/A
Completed NCT05408416 - Comparison of Surgery Outcome Between Preoperative IVR and Intraoperative IVR in PPV for PDR N/A
Not yet recruiting NCT04464694 - Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema Phase 4
Not yet recruiting NCT03633266 - Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy N/A
Completed NCT03490318 - Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
Completed NCT01627977 - Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy Phase 3
Completed NCT00776763 - Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab Phase 2
Terminated NCT00563043 - Changes in Electroretinogram and Contrast Sensitivity After PASCAL Treatment Phase 4
Terminated NCT00563628 - Changes in Macular Thickness After Patterns Scan Laser Phase 4
Completed NCT00682240 - Morphological and Functional Retinal Changes Following Retinal Photocoagulation Phase 4
Completed NCT00446381 - Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema) N/A
Completed NCT02879422 - Genetic Markers and Proliferative Diabetic Retinopathy N/A
Enrolling by invitation NCT02911311 - Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy N/A
Recruiting NCT05514925 - Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy Phase 4