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

Age-Related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00455871
• Other study ID #: 06-0769
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2007
• Last updated: May 6, 2008
• Start date: April 2007
• Est. completion date: October 2010

Study information

• Verified date: May 2008
• Source: Barnes Retina Institute
• Contact: Pamela A Light, CCRC
• Phone: 314-367-1278
• Email: bristudies[@]barnesretinainstitute.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• reduced fluence photodynamic therapy with Visudyne
reduced fluence photodynamic therapy with visudyne
• Lucentis
Lucentis intravitreal injection

Locations

Country	Name	City	State
United States	Barnes Retina Institute	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Barnes Retina Institute	QLT Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety of the combination therapy		12 months and 24 months	Yes
Primary	To assess efficacy of the two timing regimens		12 months and 24 months	Yes
Secondary	To evaluate the number of Lucentis injections and the number of PDT treatments required during the study		12 months and 24 months	Yes