Macular DegenerationPhase 3NCT00051129
Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)
A Phase 3 study testing Anecortave Acetate 15 mg sterile suspension in people with Macular Degeneration and Maculopathy, Age-Related, run by Alcon Research.
Trial summary
The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies
- What is being tested?
- Anecortave Acetate 15 mg sterile suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to May 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
- Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Under 50 years.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-Related Macular Degeneration.
The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).
- Conditions
- Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related
- Being tested
- Anecortave Acetate 15 mg sterile suspension, Anecortave Acetate Vehicle
- Keywords
- AMD, anecortave acetate, wet AMD, age-related macular degeneration, Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related
- 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 15 mg sterile suspensionDrug
0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection
Anecortave Acetate VehicleOther
Administered as a posterior juxtascleral injection
| Study group | Role | What they receive |
|---|---|---|
| Anecortave Acetate | Experimental | Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18) Receives: Drug: Anecortave Acetate 15 mg sterile suspension |
| Anecortave Acetate Vehicle | Placebo comparator | Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18) Receives: Other: Anecortave Acetate Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in logMAR visual acuity score at 12 months
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 Jan 2003 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 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
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051129
- Sponsor's protocol ID
- C-02-27
- Status last verified
- Aug 2008
- First submitted
- 3 Jan 2003
- Last updated
- 28 Nov 2012
- Results posted
- No
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
- An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-Related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT00051129
- Acronym / sponsor ID
- C-02-27
- Conditions
- Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related
- Keywords
- AMD, anecortave acetate, wet AMD, age-related macular degeneration, Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 Jan 2003 (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 anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Anecortave Acetate | Experimental | Drug: Anecortave Acetate 15 mg sterile suspensionPosterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18) |
| Anecortave Acetate Vehicle | Placebo comparator | Other: Anecortave Acetate VehiclePosterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Under 50 years.
- 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 15 mg sterile suspension0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection | Drug | Anecortave Acetate |
| Anecortave Acetate VehicleAdministered as a posterior juxtascleral injection | Other | Anecortave Acetate Vehicle |
Primary outcome
Mean change from baseline in logMAR visual acuity score at 12 months
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anecortave Acetate 15 mg sterile suspension in people with Macular Degeneration and Maculopathy, Age-Related, run by Alcon Research.
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.
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 from baseline in logMAR visual acuity score at 12 months (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.