Combination Therapy for Age-Related Macular Degeneration.
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.
3 other identifiers
interventional
103
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2006
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 14, 2006
CompletedFirst Posted
Study publicly available on registry
September 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedSeptember 28, 2011
September 1, 2011
2.6 years
September 14, 2006
September 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
To compare between treatment groups:
1 year
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
Lesion growth and activity over the study period.
1 year
Contrast sensitivity.
1 year
The rate of cataract progression.
1 year
- +1 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALReduced fluence PDT plus intravitreal Kenalog (2 mg) plus intravitreal Avastin 1.25 mg
2
EXPERIMENTALReduced fluence PDT plus intravitreal Avastin
3
EXPERIMENTALIntravitreal Avastin and sham reduced fluence PDT
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
The University of Alberta and Capital Health
Edmonton, Alberta, T5H 3V9, Canada
The University of British Columbia
Vancouver, British Columbia, V5Z 3N9, Canada
Dr. Stanley G. Shortt
Victoria, British Columbia, V8V 4X3, Canada
Ivey Eye Institute, St. Joseph's Health Care Centre
London, Ontario, N6A 4G5, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4M 3M5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas G. Sheidow, MD
The University of Western Ontario
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vitreoretinal Surgeon, Associate professor of Ophthalmology
Study Record Dates
First Submitted
September 14, 2006
First Posted
September 15, 2006
Study Start
September 1, 2006
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
September 28, 2011
Record last verified: 2011-09