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

NCT00457678 | Withdrawn Phase 2

• 1 other identifier: TAPER
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Age Related Macular Degeneration

Keywords

Vision loss; Retina; VEG-F; Fovea; AMD

Interventions

Visudyne DRUG

Lucentis DRUG

Dexamethasone DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vitreous -Retina- Macula Consultants of New York: lead
• QLT Inc.: collaborator

MeSH Terms

Conditions

Macular Degeneration; Vision Disorders

Interventions

Verteporfin; Ranibizumab; Dexamethasone

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: January 1, 2007
• Primary Completion: December 4, 2007
• Study Completion: December 4, 2007
• Last Updated: August 23, 2017

Record last verified: 2017-08