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

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ClinicalTrials.gov Identifier: NCT00457678
Recruitment Status : Withdrawn (Site did not enroll any patients to the study.)
First Posted : April 6, 2007
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
QLT Inc.
Information provided by (Responsible Party):
Vitreous -Retina- Macula Consultants of New York

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

  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.


Study Type : Interventional  (Clinical Trial)
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)
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
Estimated Study Start Date : January 2007
Actual Primary Completion Date : December 4, 2007
Actual Study Completion Date : December 4, 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab





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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier: NCT00457678     History of Changes
Other Study ID Numbers: TAPER
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

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
Ranibizumab
BB 1101
Verteporfin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Photosensitizing Agents
Dermatologic Agents