Overview

Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

Status:
Terminated
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized, open-label Phase II study evaluating the safety and efficacy of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jumper, J. Michael, M.D.
Collaborator:
Genentech, Inc.
Treatments:
Ranibizumab
Criteria
Inclusion Criteria:

- Pre-PRP protocol refraction, fluorescein angiography, and optical coherence tomography
AND 7-14 day post-PRP OCT

- Ability to provide written informed consent and comply with study assessments for the
full duration of the study

- Age 21 years or older

- Previously untreated PDR patients with high risk characteristics who develop edema
within 7-14 days post PRP therapy. This edema, determined by a masked investigator,
will be characterized as either increased foveal thickness (>10% increase from pre-PRP
foveal thickness), and/or increased macular volume on OCT (>10% increase from pre-PRP
macular volume).

Exclusion Criteria:

- Pregnancy (positive pregnancy test) prior to enrollment in the study

- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated.

- Participation in another simultaneous medical investigation or trial

- Pre-PRP clinically significant diabetic macular edema (CSME) that would make the
patient eligible for macular laser prior to PRP

- Neovascularization of the iris or neovascular glaucoma

- Increased central foveal thickness for any other reason

- Concurrent macular diseases that could confound the results of this study

- Prior vitrectomy in the study eye

- Prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab,
bevacizumab or triamcinolone acetonide