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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Vitreous -Retina- Macula Consultants of New York.
Recruitment status was  Available
Sponsor:
Collaborator:
QLT Inc.
Information provided by:
Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier:
NCT00457678
First received: April 4, 2007
Last updated: April 15, 2008
Last verified: April 2007
  Purpose

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457678

Contacts
Contact: Mehran Kavoosi, BSc 604-742-1025 kavoosi.mehran@gmail.com
Contact: Jason Slakter, MD 212-861-9797 jslakter@aol.com

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

No publications provided

ClinicalTrials.gov Identifier: NCT00457678     History of Changes
Other Study ID Numbers: TAPER
Study First Received: April 4, 2007
Last Updated: April 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Vitreous -Retina- Macula Consultants of New York:
Vision loss
Retina
VEG-F
Fovea
AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Verteporfin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Photosensitizing Agents
Radiation-Sensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014