Macular DegenerationPhase 3NCT00299507
Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)
A Phase 3 study testing Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/mL in people with Macular Degeneration, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Apr 2008
- Phase
- Phase 3
- 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
- Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Less than 50 years of age.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)
The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).
- Conditions
- Macular Degeneration
- Being tested
- Anecortave Acetate Sterile Suspension, 30 mg/mL, Anecortave Acetate Sterile Suspension, 60 mg/mL, Anecortave Acetate Vehicle
- Keywords
- exudative AMD, age-related macular degeneration (AMD)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anecortave Acetate Sterile Suspension, 30 mg/mLDrug
One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
Anecortave Acetate Sterile Suspension, 60 mg/mLDrug
One 0.5 mL posterior juxtascleral depot injection at 6 month intervals
Anecortave Acetate VehicleOther
One 0.5 mL sham injection at 6 month intervals
| Study group | Role | What they receive |
|---|---|---|
| 15 mg Anecortave Acetate, 3 month intervals | Experimental | Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months). Receives: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL |
| 15 mg Anecortave Acetate, 6 month intervals | Experimental | Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). Receives: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL |
| 30 mg Anecortave Acetate, 6 month intervals | Experimental | Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). Receives: Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL |
| Anecortave Acetate Vehicle | Sham comparator | One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months). Receives: Other: Anecortave Acetate Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
Measured: Month 12
Secondary outcomes (1)
Mean change in lesion growth at Month 12 from baseline
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startMar 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon Investigators, Principal investigator, Alcon ResearchPatricia Zilliox, Ph.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299507
- Sponsor's protocol ID
- C-04-59
- Status last verified
- Sep 2009
- First submitted
- 3 Mar 2006
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00299507
- Acronym / sponsor ID
- C-04-59
- Conditions
- Macular Degeneration
- Keywords
- exudative AMD, age-related macular degeneration (AMD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 7 Mar 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 purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 15 mg Anecortave Acetate, 3 month intervals | Experimental | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mLAnecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months). |
| 15 mg Anecortave Acetate, 6 month intervals | Experimental | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mLAnecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). |
| 30 mg Anecortave Acetate, 6 month intervals | Experimental | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mLAnecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). |
| Anecortave Acetate Vehicle | Sham comparator | Other: Anecortave Acetate VehicleOne 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Less than 50 years of age.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Anecortave Acetate Sterile Suspension, 30 mg/mLOne 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals | Drug | 15 mg Anecortave Acetate, 3 month intervals, 15 mg Anecortave Acetate, 6 month intervals |
| Anecortave Acetate Sterile Suspension, 60 mg/mLOne 0.5 mL posterior juxtascleral depot injection at 6 month intervals | Drug | 30 mg Anecortave Acetate, 6 month intervals |
| Anecortave Acetate VehicleOne 0.5 mL sham injection at 6 month intervals | Other | Anecortave Acetate Vehicle |
Primary outcome
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
Time frame: Month 12
1 secondary outcome
Mean change in lesion growth at Month 12 from baseline
Time frame: Month 12
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 Nov 2012.
Related trials for Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
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.
Alcon Investigators principal investigator
Alcon Research
Patricia Zilliox, Ph.D. study director
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/mL in people with Macular Degeneration, run by Alcon Research at 1 site in United States.
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 2 inclusion and 2 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 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline (time frame: Month 12). 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 Nov 2012.