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Combination Therapy for Age-Related Macular Degeneration.

Primary Purpose

Age Related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Avastin (Bevacizumab)

Bevacizumab

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Choroidal Neovascularization, Photodynamic Therapy, Age Related Macular Degeneration, Triamcinolone Acetonide, Avastin, Visudyne

Eligibility Criteria

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

Inclusion Criteria:

Choroidal neovascularization (CNV) secondary to age-related macular. All lesion subtypes, based upon IVFA evaluation will be included.
CNV under the geometric centre of the foveal avascular zone.
Evidence of choroidal neovascular activity as suggested by one of the following: sub-retinal lipid, sub-retinal hemorrhage, and documented loss of 3 lines of vision within the last three months.
Greatest linear dimension of the lesion </= 5400 um.
Visual acuity of between 20/32 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 metres.
Willingness and ability to participate and provide written informed consent

Exclusion Criteria:

Individuals with choroidal neovascularization from causes other than AMD.
Individuals physically unable to tolerate intravenous fluorescein angiography or Verteporfin injections. (Specifically, individuals with inadequate venous access or an allergy/sensitivity to fluorescein dye/porphyrins will be excluded.)
Any intraocular surgery within 3 months in the study eye.
Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye.
Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
Individuals with physical or mental disabilities that prevent accurate vision testing.
History of treatment of CNV in study eye other than extrafoveal confluent laser photocoagulation.
Prior photodynamic therapy for CNV in the study eye.
Active hepatitis or clinically significant liver disease
Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
Subjects who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks.
Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
Women of child-bearing potential who are not on two forms of effective contraception during the trial and for at least 60 days following the last dose of study medications.

Sites / Locations

The University of Alberta and Capital Health
The University of British Columbia
Dr. Stanley G. Shortt
Ivey Eye Institute, St. Joseph's Health Care Centre
Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

Reduced fluence PDT plus intravitreal Kenalog (2 mg) plus intravitreal Avastin 1.25 mg

Reduced fluence PDT plus intravitreal Avastin

Intravitreal Avastin and sham reduced fluence PDT

Outcomes

Primary Outcome Measures

To investigate whether patients with CNV secondary to AMD, receiving triple or double therapy compared to monotherapy with Avastin, will reduce the intervention rate with equivalent safety and efficacy.

Secondary Outcome Measures

To compare between treatment groups:

Whether combination therapy with rPDT + iA and rPDT + iAK in patients with sub-foveal CNVM of all types secondary to ARMD will result in a significant improvement in visual acuity defined as 2 or more lines (10+ letters) on a standardized ETDRS chart c

Lesion growth and activity over the study period.

Contrast sensitivity.

The rate of cataract progression.

Central retinal thickness via Optical Coherence Tomography (OCT).

Full Information

NCT ID

NCT00376701

First Posted

September 14, 2006

Last Updated

September 27, 2011

Sponsor

Lawson Health Research Institute

Collaborators

QLT Inc., Canadian Retinal Trials Group

1. Study Identification

Unique Protocol Identification Number

NCT00376701

Brief Title

Combination Therapy for Age-Related Macular Degeneration.

Official Title

Combination Therapy in Neovascular Age-Related Macular Degeneration (AMD): A Three-armed, Randomized, Prospective Clinical Trial of Low Fluence Photodynamic Therapy(rPDT) With Adjunctive Avastin and Triamcinolone Acetonide (Kenalog)(Triple Therapy) Versus rPDT With Adjunctive Avastin (Double Therapy) Versus Monotherapy With Avastin.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

Collaborators

QLT Inc., Canadian Retinal Trials Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary purpose of the study is to investigate whether patients with Choroidal Neovascularization secondary to Age-related Macular Degeneration, receiving triple or double therapy compared to monotherapy with Avastin will reduce the intervention rate with equivalent safety and efficacy.

Detailed Description

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in developed countries throughout the world.The beneficial therapeutic effect of Photodynamic Therapy (PDT)in the treatment of AMD is modest. The treatment benefit of PDT may be moderated by PDT-induced, non-selective effects in the choroidal circulation (resulting in hypoxia-induced stimulation of angiogenesis through increased vascular endothelial growth factor (VEGF)production), direct injury to the retinal pigment epithelium, and subretinal fluid/hemorrhage or post-treatment inflammation secondary to PDT. There is potential that supplemental Avastin (through VEGF inhibition) or intravitreal Triamcinolone Acetonide (ITA) treatments (through non-specific membrane stabilizing, anti-neovascular, and anti-inflammatory activities) could minimize the effect of these processes, enhancing the efficacy of PDT. Presently, PDT, the current gold standard,in combination with Avastin and/or Kenalog is being more widely used in exactly this fashion and may become the standard of care without the necessary randomized clinical trial. However, the treatment benefit of these interventions is uncertain as is their safety profile. This randomized, controlled trial addresses the potential supplemental therapeutic effect of intravitreal injection of Triamcinolone Acetonide and/or Avastin in conjunction with photodynamic therapy for the treatment of sub-foveal CNVM secondary to AMD.

6. Conditions and Keywords

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

Age Related Macular Degeneration

Keywords

Choroidal Neovascularization, Photodynamic Therapy, Age Related Macular Degeneration, Triamcinolone Acetonide, Avastin, Visudyne

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Reduced fluence PDT plus intravitreal Kenalog (2 mg) plus intravitreal Avastin 1.25 mg

Arm Title

Arm Type

Experimental

Arm Description

Reduced fluence PDT plus intravitreal Avastin

Arm Title

Arm Type

Experimental

Arm Description

Intravitreal Avastin and sham reduced fluence PDT

Intervention Type

Drug

Intervention Name(s)

Avastin (Bevacizumab)

Intervention Description

Avastin 1.25 mg intravitreal

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Intravitreal 1.25 mg

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Intravitreal 1.25 mg

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Intravitreal Avastin 1.25 mg and sham reduced fluence PDT

Primary Outcome Measure Information:

Title

Time Frame

1 year

Secondary Outcome Measure Information:

Title

To compare between treatment groups:

Time Frame

1 year

Title

Time Frame

1 year

Title

Lesion growth and activity over the study period.

Time Frame

1 year

Title

Contrast sensitivity.

Time Frame

1 year

Title

The rate of cataract progression.

Time Frame

1 year

Title

Central retinal thickness via Optical Coherence Tomography (OCT).

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Choroidal neovascularization (CNV) secondary to age-related macular. All lesion subtypes, based upon IVFA evaluation will be included. CNV under the geometric centre of the foveal avascular zone. Evidence of choroidal neovascular activity as suggested by one of the following: sub-retinal lipid, sub-retinal hemorrhage, and documented loss of 3 lines of vision within the last three months. Greatest linear dimension of the lesion </= 5400 um. Visual acuity of between 20/32 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 metres. Willingness and ability to participate and provide written informed consent Exclusion Criteria: Individuals with choroidal neovascularization from causes other than AMD. Individuals physically unable to tolerate intravenous fluorescein angiography or Verteporfin injections. (Specifically, individuals with inadequate venous access or an allergy/sensitivity to fluorescein dye/porphyrins will be excluded.) Any intraocular surgery within 3 months in the study eye. Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye. Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome. Individuals with physical or mental disabilities that prevent accurate vision testing. History of treatment of CNV in study eye other than extrafoveal confluent laser photocoagulation. Prior photodynamic therapy for CNV in the study eye. Active hepatitis or clinically significant liver disease Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past. Subjects who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections. Women of child-bearing potential who are not on two forms of effective contraception during the trial and for at least 60 days following the last dose of study medications.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas G. Sheidow, MD

Organizational Affiliation

The University of Western Ontario

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Alberta and Capital Health

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5H 3V9

Country

Canada

Facility Name

The University of British Columbia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 3N9

Country

Canada

Facility Name

Dr. Stanley G. Shortt

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 4X3

Country

Canada

Facility Name

Ivey Eye Institute, St. Joseph's Health Care Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4M 3M5

Country

Canada

12. IPD Sharing Statement

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Combination Therapy for Age-Related Macular Degeneration.

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