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

Expanded access is currently available for this treatment.
Verified December 2015 by Vitreous -Retina- Macula Consultants of New York
QLT Inc.
Information provided by (Responsible Party):
Vitreous -Retina- Macula Consultants of New York Identifier:
First received: April 4, 2007
Last updated: December 30, 2015
Last verified: December 2015
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 Intervention
Age Related Macular Degeneration
Drug: Visudyne
Drug: Lucentis
Drug: Dexamethasone

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:

Further study details as provided by Vitreous -Retina- Macula Consultants of New York:

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

  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.


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00457678

Contact: Mehran Kavoosi, BSc 604-742-1025
Contact: Jason Slakter, MD 212-861-9797

Sponsors and Collaborators
Vitreous -Retina- Macula Consultants of New York
QLT Inc.
  More Information

Responsible Party: Vitreous -Retina- Macula Consultants of New York Identifier: NCT00457678     History of Changes
Other Study ID Numbers: TAPER 
Study First Received: April 4, 2007
Last Updated: December 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Vitreous -Retina- Macula Consultants of New York:
Vision loss

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Growth Inhibitors
Growth Substances
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protease Inhibitors processed this record on May 25, 2016