Age Related Macular DegenerationPhase 2NCT00376701
Combination Therapy for Age-Related Macular Degeneration.
A Phase 2 study testing Avastin (Bevacizumab) and Bevacizumab in people with Age Related Macular Degeneration, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Avastin (Bevacizumab) and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 5 sitesCanada
- Study dates
- Sep 2006to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
The University of Alberta and Capital Health
Edmonton, Alberta, T5H 3V9
Ivey Eye Institute, St. Joseph's Health Care Centre
London, Ontario, N6A 4G5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4M 3M5
The University of British Columbia
Vancouver, British Columbia, V5Z 3N9
Dr. Stanley G. Shortt
Victoria, British Columbia, V8V 4X3
About this study
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.
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.
Read the 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.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Avastin (Bevacizumab), Bevacizumab
- Keywords
- Choroidal Neovascularization, Photodynamic Therapy, Age Related Macular Degeneration, Triamcinolone Acetonide, Avastin, Visudyne
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin (Bevacizumab)Drug
Avastin 1.25 mg intravitreal
BevacizumabDrug
Also called Avastin
Intravitreal 1.25 mg
BevacizumabDrug
Also called Avastin
Intravitreal 1.25 mg
BevacizumabDrug
Also called Avastin
Intravitreal Avastin 1.25 mg and sham reduced fluence PDT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Reduced fluence PDT plus intravitreal Kenalog (2 mg) plus intravitreal Avastin 1.25 mg Receives: Drug: Avastin (Bevacizumab); Drug: Bevacizumab |
| 2 | Experimental | Reduced fluence PDT plus intravitreal Avastin Receives: Drug: Avastin (Bevacizumab); Drug: Bevacizumab |
| 3 | Experimental | Intravitreal Avastin and sham reduced fluence PDT Receives: Drug: Avastin (Bevacizumab); Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
To compare between treatment groups:
Measured: 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
Measured: 1 year
Lesion growth and activity over the study period.
Measured: 1 year
Contrast sensitivity.
Measured: 1 year
The rate of cataract progression.
Measured: 1 year
Central retinal thickness via Optical Coherence Tomography (OCT).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- QLT Inc., Canadian Retinal Trials Group
- Responsible party
- Principal investigator, Thomas G. Sheidow, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Thomas G. Sheidow, MD, Principal investigator, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376701
- Sponsor's protocol ID
- R-06-441
- Other IDs
- Health Canada Control #106990, 9427-U0207/2-21C
- Status last verified
- Sep 2011
- First submitted
- 14 Sep 2006
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00376701
- Acronym / sponsor ID
- R-06-441
- Conditions
- Age Related Macular Degeneration
- Keywords
- Choroidal Neovascularization, Photodynamic Therapy, Age Related Macular Degeneration, Triamcinolone Acetonide, Avastin, Visudyne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- QLT Inc., Canadian Retinal Trials Group
- Study start
- Sep 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Avastin (Bevacizumab), Drug: BevacizumabReduced fluence PDT plus intravitreal Kenalog (2 mg) plus intravitreal Avastin 1.25 mg |
| 2 | Experimental | Drug: Avastin (Bevacizumab), Drug: BevacizumabReduced fluence PDT plus intravitreal Avastin |
| 3 | Experimental | Drug: Avastin (Bevacizumab), Drug: BevacizumabIntravitreal Avastin and sham reduced fluence PDT |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avastin (Bevacizumab)Avastin 1.25 mg intravitreal | Drug | 1, 2, 3 |
| BevacizumabAlso: AvastinIntravitreal 1.25 mg | Drug | 1 |
| BevacizumabAlso: AvastinIntravitreal 1.25 mg | Drug | 2 |
| BevacizumabAlso: AvastinIntravitreal Avastin 1.25 mg and sham reduced fluence PDT | Drug | 3 |
Primary outcome
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
6 secondary outcomes
To compare between treatment groups:
Time frame: 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
Time frame: 1 year
Lesion growth and activity over the study period.
Time frame: 1 year
Contrast sensitivity.
Time frame: 1 year
The rate of cataract progression.
Time frame: 1 year
Central retinal thickness via Optical Coherence Tomography (OCT).
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas G. Sheidow, MD principal investigator
The University of Western Ontario
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin (Bevacizumab) and Bevacizumab in people with Age Related Macular Degeneration, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2011.