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

Sponsors and Collaborators:	Barnes Retina Institute QLT Inc
Information provided by:	Barnes Retina Institute
ClinicalTrials.gov Identifier:	NCT00455871

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

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Verteporfin Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

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
Lucentis plus Reduced Fluence PDT same day: Active Comparator	Drug: reduced fluence photodynamic therapy with Visudyne reduced fluence photodynamic therapy with visudyne Drug: Lucentis Lucentis intravitreal injection
Lucentis plus reduced fluence PDT 1-2 weeks later: Active Comparator	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

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

Keywords provided by Barnes Retina Institute:

macular degeneration

Study placed in the following topic categories:

Photosensitizing Agents
Radiation-Sensitizing Agents
Eye Diseases
Verteporfin

Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Eye Diseases
Physiological Effects of Drugs
Verteporfin

Retinal Degeneration
Macular Degeneration
Dermatologic Agents
Pharmacologic Actions
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009