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Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced Fluence PDT With Visudyne in Patients With Exudative AMD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Barnes Retina Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
QLT Inc.
Information provided by:
Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT00455871
First received: April 2, 2007
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.


Condition Intervention
Age-Related Macular Degeneration
Drug: reduced fluence photodynamic therapy with Visudyne
Drug: Lucentis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Site, Comparative, Pilot Study of the Treatment Effects of Combination Therapy of Lucentis (Ranibizumab) Plus Reduced Fluence Photodynamic Therapy With Visudyne in Patients With Exudative Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by Barnes Retina Institute:

Primary Outcome Measures:
  • To assess the safety of the combination therapy [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: Yes ]
  • To assess efficacy of the two timing regimens [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the number of Lucentis injections and the number of PDT treatments required during the study [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lucentis plus Reduced Fluence PDT same day Drug: reduced fluence photodynamic therapy with Visudyne
reduced fluence photodynamic therapy with visudyne
Drug: Lucentis
Lucentis intravitreal injection
Active Comparator: Lucentis plus reduced fluence PDT 1-2 weeks later Drug: reduced fluence photodynamic therapy with Visudyne
reduced fluence photodynamic therapy with visudyne
Drug: Lucentis
Lucentis intravitreal injection

Detailed Description:

The study will have two treatment groups. Each group will receive intravitreal injections (injection of medication in the jelly-like part of the back of the eye). One group (Group1) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by reduced fluence Photodynamic Therapy (PDT) with Visudyne ® 1-2 weeks later. The other group (Group 2) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by Photodynamic Therapy with Visudyne on the same day. patients will be assigned at random to receive one of the two treatments arms in the study. The dose received at the first injection will be the same dose received throughout the study.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to give informed consent
  • Treatment- naïve patients with active, subfoveal, exudative AMD
  • Patients with visual acuity of 20/40-20/320 in the study eye
  • Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size Total area of lesion components other that CNV must be less than 50% of the total lesion size
  • The lesion must be < 5400microns in greatest linear dimension (GLD)
  • Lesion size < 10 DA
  • Occult with no classic CNV lesions must have presumed recent disease progression:

    1. Blood associated with the lesion at baseline
    2. Loss of visual acuity in the previous 3 months: a: > 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
    3. > 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
  • Previous treatment for CNV with anti-VEGF agents, intraocular steroids and/or Photodynamic therapy with Visudyne® in the study eye
  • Geographic atrophy or fibrosis in the study eye
  • Intraocular surgery within 6 weeks of enrollment
  • Subretinal hemorrhage > 50% of the total lesion
  • Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
  • Patients with severe disciform scarring.
  • Inability to make study visits
  • Advanced glaucoma
  • Allergies to porfins or a known hypersensitivity to any component of Visudyne®
  • Patients with porphyria
  • Pregnancy or lactation
  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 ClinicalTrials.gov identifier: NCT00455871

Contacts
Contact: Pamela A Light, CCRC 314-367-1278 ext 2287 bristudies@barnesretinainstitute.com
Contact: Rhonda F Weeks 314-367-1278 ext 2240 bristudies@barnesretinainstitute.com

Locations
United States, Missouri
Barnes Retina Institute Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Gaurav K Shah, MD         
Sponsors and Collaborators
Barnes Retina Institute
QLT Inc.
Investigators
Principal Investigator: Gaurav K. Shah, MD Barnes Retina Institute
  More Information

No publications provided

Responsible Party: Gaurav Shah, M.d., Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT00455871     History of Changes
Other Study ID Numbers: 06-0769
Study First Received: April 2, 2007
Last Updated: May 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Barnes Retina Institute:
macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Verteporfin
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014