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

Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00457678
• Other study ID #: TAPER
• Status: Withdrawn
• Phase: Phase 2
• First received: April 4, 2007
• Last updated: August 21, 2017
• Start date: January 2007
• Est. completion date: December 4, 2007

Study information

• Verified date: August 2017
• Source: Vitreous -Retina- Macula Consultants of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

1. continuation of Lucentis monotherapy

2. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 4, 2007
• Est. primary completion date: December 4, 2007
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Main Exclusion Criteria:

• Subfoveal geographic atrophy or subfoveal fibrosis in the study eye

• Intraocular surgery within 3 months of enrollment

• Inability to attend the protocol-required visits

• Known allergies or hypersensitivity to any of the study treatments

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Visudyne

• Lucentis

• Dexamethasone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vitreous -Retina- Macula Consultants of New York	QLT Inc.