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Combination Therapy for Age-Related Macular Degeneration.

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ClinicalTrials.gov Identifier: NCT00376701
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : September 28, 2011
Sponsor:
Collaborators:
QLT Inc.
Canadian Retinal Trials Group
Information provided by (Responsible Party):
Thomas G. Sheidow, Lawson Health Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: Avastin (Bevacizumab) Drug: Bevacizumab Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Reduced fluence PDT plus intravitreal Kenalog (2 mg) plus intravitreal Avastin 1.25 mg
 Drug: Avastin (Bevacizumab)
Avastin 1.25 mg intravitreal

Drug: Bevacizumab
Intravitreal 1.25 mg
Other Name: Avastin
Experimental: 2
Reduced fluence PDT plus intravitreal Avastin
 Drug: Avastin (Bevacizumab)
Avastin 1.25 mg intravitreal

Drug: Bevacizumab
Intravitreal 1.25 mg
Other Name: Avastin
Experimental: 3
Intravitreal Avastin and sham reduced fluence PDT
 Drug: Avastin (Bevacizumab)
Avastin 1.25 mg intravitreal

Drug: Bevacizumab
Intravitreal Avastin 1.25 mg and sham reduced fluence PDT
Other Name: Avastin


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To compare between treatment groups: [ Time Frame: 1 year ]
  2. 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 [ Time Frame: 1 year ]
  3. Lesion growth and activity over the study period. [ Time Frame: 1 year ]
  4. Contrast sensitivity. [ Time Frame: 1 year ]
  5. The rate of cataract progression. [ Time Frame: 1 year ]
  6. Central retinal thickness via Optical Coherence Tomography (OCT). [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376701


Locations
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Canada, Alberta
The University of Alberta and Capital Health
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
The University of British Columbia
Vancouver, British Columbia, Canada, V5Z 3N9
Dr. Stanley G. Shortt
Victoria, British Columbia, Canada, V8V 4X3
Canada, Ontario
Ivey Eye Institute, St. Joseph's Health Care Centre
London, Ontario, Canada, N6A 4G5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4M 3M5
Sponsors and Collaborators
Lawson Health Research Institute
QLT Inc.
Canadian Retinal Trials Group
Investigators
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Principal Investigator: Thomas G. Sheidow, MD University of Western Ontario, Canada
More Information
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Responsible Party: Thomas G. Sheidow, Vitreoretinal Surgeon, Associate professor of Ophthalmology, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00376701    
Other Study ID Numbers: R-06-441
Health Canada Control #106990
9427-U0207/2-21C
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011
Keywords provided by Thomas G. Sheidow, Lawson Health Research Institute:
Choroidal Neovascularization
Photodynamic Therapy
Age Related Macular Degeneration
 Triamcinolone Acetonide
Avastin
Visudyne
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors