Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) (EXCITE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Age Related Macular Degeneration

Treatments: Drug: Ranibizumab 0.3 mg monthly; Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly; Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly

Study type: Interventional

Funder types: Industry

Identifiers

NCT00275821

CRFB002A2302

Details and patient eligibility

About

The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.

Enrollment: 353 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
• Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)

Exclusion criteria

• Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
• History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery.
• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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353 participants in 3 patient groups

Ranibizumab 0.3 mg - 3 times monthly, then quarterly

Experimental group

Treatment:

Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly

Ranibizumab 0.5 mg - 3 times monthly, then quarterly

Experimental group

Treatment:

Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly

Ranibizumab 0.3 mg monthly

Active Comparator group

Treatment:

Drug: Ranibizumab 0.3 mg monthly