Overview

Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Ranibizumab
Criteria
Inclusion Criteria:

- Patients with Type 1 or Type 2 diabetes mellitus according to American Diabetes
Association (ADA) or World Health Organization (WHO) guidelines with HbA1c not more
than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or
pharmacological treatment for diabetes.

- Patients with visual impairment due to focal or diffuse Diabetic Macular Edema in at
least one eye who are eligible for laser treatment in the opinion of the investigator.
If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit
1, will be selected for study treatment unless, based on medical reasons, the
investigator deems the other eye the more appropriate candidate for study treatment.

- The study eye must fulfill the following criteria at Visit 1:

- Best-Corrected Visual Acuity (BCVA) score between 78 and 39 letters, inclusively,
using Early Treatment of Diabetic Retinopathy (ETDRS) chart-like visual acuity
testing charts at a testing distance of 4 meters (approximate Snellen equivalent
of 20/32 to 20/160).

- Decrease in vision is due to DME and not due to other causes, in the opinion of
the investigator.

- Medication for the management of diabetes must have been stable within 3 months
prior to randomization and is expected to remain stable during the course of the
study.

Exclusion Criteria:

- Ocular concomitant conditions/ diseases:

- Concomitant conditions in the study eye which could, in the opinion of the
investigator, prevent the improvement of visual acuity on study treatment.

- Active intraocular inflammation in either eye.

- Any active infection in either eye.

- History of uveitis in either eye.

- Uncontrolled glaucoma in either eye.

- Ocular treatments:

- Panretinal laser photocoagulation in the study eye within 6 months prior to or
during the study.

- Focal/grid laser photocoagulation in the study eye within 3 months prior to study
entry.

- Systemic conditions or treatments:

- History of stroke

- Renal failure requiring dialysis or renal transplant or renal insufficiency with
creatinine level > 2.0 mg/dL.

- Untreated diabetes mellitus

- Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg

- Compliance/ Administrative:

- Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply