Second Line Therapy to Treat Age-related Macular Degeneration (AMD) for Patients Not Responding Well to Lucentis Therapy by Itself

Sponsor

Vitreous -Retina- Macula Consultants of New York (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00457678

Collaborator

QLT Inc. (Industry)

Enrollment

11.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate that Visudyne-Lucentis-dexamethasone (V-L-D) triple therapy will give similar efficacy and safety results as Lucentis monotherapy.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: Visudyne Drug: Lucentis Drug: Dexamethasone	Phase 2

Detailed Description

Study Design:

Patients who have received 2-6 previous treatments with Lucentis monotherapy and who have exudative activity associated with the choroidal neovascularization (CNV) lesion, as confirmed by fluorescein angiography (FA) or optical coherence tomography (OCT), will be eligible. Patients will be randomly assigned at 4-8 weeks after the previous Lucentis treatment to either

continuation of Lucentis monotherapy
triple therapy with half fluence Visudyne (300 mW/cm2 for 83 seconds) followed within 2 hours by intravitreal Lucentis 0.5 mg (first injection) and then dexamethasone 0.5 mg (second injection) (V-L-D).

Both groups will receive treatment at baseline and then as needed (PRN), according to retreatment criteria, with monthly assessments thereafter for 12 months. In the triple therapy group, patients may only be retreated with the V-L-D combination at intervals of no less than 3 months; if retreatment is needed 1 or 2 months after a previous V-L-D treatment, the patient will receive a Lucentis injection at that visit; however, if retreatment is needed and the previous V-L-D treatment was at least 3 months prior, then V-L-D treatment is mandatory. OCT, visual acuity (VA) testing, and possibly FA will be conducted at each assessment visit to define the need for retreatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients with AMD will be randomly assigned to one of 2 treatments: Continuation of previous Lucentis monotherapy (50 patients) V-L-D triple therapy with half fluence (300 mW/cm2 for 83 seconds) Visudyne followed within 2 hours by intravitreal Lucentis 0.5 mg (first injection) and intravitreal dexamethasone 0.5 mg (second injection) (50 patients)Patients withAMD will be randomly assigned to one of 2 treatments:Continuation of previous Lucentis monotherapy (50 patients) V-L-D triple therapy with half fluence (300 mW/cm2 for 83 seconds) Visudyne followed within 2 hours by intravitreal Lucentis 0.5 mg (first injection) and intravitreal dexamethasone 0.5 mg (second injection) (50 patients)

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Single-Masked Comparison of Lucentis™ Monotherapy With Triple Therapy of Reduced Fluence Visudyne-Lucentis-Dexamethasone (V-L-D) in Patients With CNV Secondary to AMD as Second Line Therapy After Lucentis Monotherapy

Anticipated Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Dec 4, 2007

Actual Study Completion Date :

Dec 4, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Main Inclusion Criteria:

Patients with subfoveal CNV due to AMD who, after 2-6 previous treatments with Lucentis monotherapy, continue to have exudative activity associated with the CNV lesion 4-8 weeks after the last treatment. Exudative activity is defined as one or more of:
CNV leakage confirmed by FA
New hemorrhage associated with the CNV lesion
Subretinal fluid or cystoid macular edema by OCT showing retinal thickness ≥ 230 μm
All lesion composition types with a lesion greatest linear dimension (GLD) ≤ 5400 microns (approximately ≤ 9 disc areas [DA])
Best corrected ETDRS VA score of 25-73 letters (approximate Snellen equivalent of 20/40-20/320)