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

Primary Purpose

Age-Related Macular Degeneration

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

reduced fluence photodynamic therapy with Visudyne

Lucentis

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Barnes Retina InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Lucentis plus Reduced Fluence PDT same day

Lucentis plus reduced fluence PDT 1-2 weeks later

Arm Description

Outcomes

Primary Outcome Measures

To assess the safety of the combination therapy

To assess efficacy of the two timing regimens

Secondary Outcome Measures

To evaluate the number of Lucentis injections and the number of PDT treatments required during the study

Full Information

NCT ID

NCT00455871

First Posted

April 2, 2007

Last Updated

May 6, 2008

Sponsor

Barnes Retina Institute

Collaborators

QLT Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00455871

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

October 2010 (Anticipated)

Study Completion Date

October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Barnes Retina Institute

Collaborators

QLT Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Macular Degeneration

Keywords

macular degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lucentis plus Reduced Fluence PDT same day

Arm Type

Active Comparator

Arm Title

Lucentis plus reduced fluence PDT 1-2 weeks later

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

reduced fluence photodynamic therapy with Visudyne

Intervention Description

reduced fluence photodynamic therapy with visudyne

Intervention Type

Drug

Intervention Name(s)

Lucentis

Intervention Description

Lucentis intravitreal injection

Primary Outcome Measure Information:

Title

To assess the safety of the combination therapy

Time Frame

12 months and 24 months

Title

To assess efficacy of the two timing regimens

Time Frame

12 months and 24 months

Secondary Outcome Measure Information:

Title

To evaluate the number of Lucentis injections and the number of PDT treatments required during the study

Time Frame

12 months and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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: Blood associated with the lesion at baseline 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 > 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pamela A Light, CCRC

Phone

314-367-1278

Ext

2287

bristudies@barnesretinainstitute.com

First Name & Middle Initial & Last Name or Official Title & Degree

Rhonda F Weeks

Phone

314-367-1278

Ext

2240

bristudies@barnesretinainstitute.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gaurav K. Shah, MD

Organizational Affiliation

Barnes Retina Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barnes Retina Institute

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gaurav K Shah, MD

12. IPD Sharing Statement

Learn more about this trial

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

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