A Prospective Masked Pilot Study Comparing Group 1 Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Group 2 Monotherapy - Intravitreal Ranibizumab Alone. (PDEX)

NCT00390208 Phase 2 COMPLETED

The purpose of this study is to compare triple therapy using Photodynamic therapy, intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with intravitreal Ranibizumab alone for the treatment of Age-Related Macular Degeneration.

Details

Lead sponsor	Bay Area Retina Associates
Phase	Phase 2
Status	COMPLETED
Enrolment	60
Start date	2006-08
Completion	2009-12

Conditions

• Age Related Macular Degeneration

Interventions

• ranibizumab, dexamethasone and verteporfin
• Ranibizumab

Primary outcomes

• Visual Acuity: Change in visual acuity by 15 or more ETDRS letters at 6 and 12 months. Non-inferiority as compared to the triple therapy arm will serve to determine efficacy for the purposes of this pilot trial. — one year

Countries

United States