Combination Therapy for Age-Related Macular Degeneration.

Age Related Macular Degeneration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376701
• Other study ID #: R-06-441
• Secondary ID: Health Canada Co
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2006
• Last updated: September 27, 2011
• Start date: September 2006
• Est. completion date: April 2009

Study information

• Verified date: September 2011
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Choroidal neovascularization (CNV) secondary to age-related macular. All lesion subtypes, based upon IVFA evaluation will be included.

2. CNV under the geometric centre of the foveal avascular zone.

3. 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.

4. Greatest linear dimension of the lesion </= 5400 um.

5. 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.

6. Willingness and ability to participate and provide written informed consent

Exclusion Criteria:

1. Individuals with choroidal neovascularization from causes other than AMD.

2. 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.)

3. Any intraocular surgery within 3 months in the study eye.

4. Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye.

5. Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.

6. Individuals with physical or mental disabilities that prevent accurate vision testing.

7. History of treatment of CNV in study eye other than extrafoveal confluent laser photocoagulation.

8. Prior photodynamic therapy for CNV in the study eye.

9. Active hepatitis or clinically significant liver disease

10. Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.

11. Subjects who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks.

12. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.

13. 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.

Study Design

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Avastin (Bevacizumab)
Avastin 1.25 mg intravitreal
• Bevacizumab
Intravitreal 1.25 mg
• Bevacizumab
Intravitreal 1.25 mg
• Bevacizumab
Intravitreal Avastin 1.25 mg and sham reduced fluence PDT

Locations

Country	Name	City	State
Canada	The University of Alberta and Capital Health	Edmonton	Alberta
Canada	Ivey Eye Institute, St. Joseph's Health Care Centre	London	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	The University of British Columbia	Vancouver	British Columbia
Canada	Dr. Stanley G. Shortt	Victoria	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Retinal Trials Group, QLT Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	To compare between treatment groups:		1 year	No
Secondary	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		1 year	No
Secondary	Lesion growth and activity over the study period.		1 year	No
Secondary	Contrast sensitivity.		1 year	No
Secondary	The rate of cataract progression.		1 year	No
Secondary	Central retinal thickness via Optical Coherence Tomography (OCT).		1 year	No