Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration

Novartis

Status and phase

Completed

Phase 2

Conditions

Age-Related Macular Degeneration (ARMD)

Treatments

Drug: ranibizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00288561

CRFB002B2201

Details and patient eligibility

About

Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal injection. The present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal CNV secondary to ARMD

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients 50 years of age or greater who have provided written informed consent
- Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component
- Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS (approximately 20/40 to 20/320)
- Willing to return for all scheduled visits

Exclusion criteria

- Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy
Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Other protocol-defined inclusion/exclusion criteria may apply