AMDPhase 2NCT00346957
A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration
A Phase 2 study testing Anecortave acetate 30 mg, Anecortave Acetate 15 mg and Anecortave Acetate 3 mg in people with AMD, run by Alcon Research.
Trial summary
The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AMD
- What is being tested?
- Anecortave acetate 30 mg, Anecortave Acetate 15 mg and Anecortave Acetate 3 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Apr 1999to Apr 2003
- 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
- Ages 50 years and over
- Other protocol-defined inclusion and exclusion criteria may apply.
Who cannot join
None listed.
About this study
The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.
- Conditions
- AMD
- Being tested
- Anecortave acetate 30 mg, Anecortave Acetate 15 mg, Anecortave Acetate 3 mg, Anecortave Acetate Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anecortave acetate 30 mgDrug
0.5ml administered onto the sclera once every six months for 24 months
Anecortave Acetate 15 mgDrug
0.5ml administered onto the sclera once every six months for 24 months
Anecortave Acetate 3 mgDrug
0.5ml administered onto the sclera once every six months for 24 months
Anecortave Acetate VehicleOther
0.5ml administered onto the sclera once every six months for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Anecortave Acetate 30 | Experimental | Not described Receives: Drug: Anecortave acetate 30 mg |
| Anecortave Acetate 15 | Experimental | Not described Receives: Drug: Anecortave Acetate 15 mg |
| Anecortave Acetate 3 | Experimental | Not described Receives: Drug: Anecortave Acetate 3 mg |
| Anecortave Acetate Vehicle | Placebo comparator | Not described 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 logMAR visual acuity at 12 months from baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startApr 1999
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 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
- NCT00346957
- Sponsor's protocol ID
- C-98-03
- Status last verified
- Mar 2012
- First submitted
- 28 Jun 2006
- Last updated
- 6 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00346957
- Acronym / sponsor ID
- C-98-03
- Conditions
- AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 4 Jul 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 the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anecortave Acetate 30 | Experimental | Drug: Anecortave acetate 30 mg |
| Anecortave Acetate 15 | Experimental | Drug: Anecortave Acetate 15 mg |
| Anecortave Acetate 3 | Experimental | Drug: Anecortave Acetate 3 mg |
| Anecortave Acetate Vehicle | Placebo comparator | Other: Anecortave Acetate Vehicle |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 50 years and over
- Other protocol-defined inclusion and exclusion criteria may apply.
Key exclusion criteria (0 listed)
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 30 mg0.5ml administered onto the sclera once every six months for 24 months | Drug | Anecortave Acetate 30 |
| Anecortave Acetate 15 mg0.5ml administered onto the sclera once every six months for 24 months | Drug | Anecortave Acetate 15 |
| Anecortave Acetate 3 mg0.5ml administered onto the sclera once every six months for 24 months | Drug | Anecortave Acetate 3 |
| Anecortave Acetate Vehicle0.5ml administered onto the sclera once every six months for 24 months | Other | Anecortave Acetate Vehicle |
Primary outcome
Mean change in logMAR visual acuity at 12 months from baseline.
Time frame: 12 months
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 6 Mar 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 2 study testing Anecortave acetate 30 mg, Anecortave Acetate 15 mg and Anecortave Acetate 3 mg in people with AMD, 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 0 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 6 Mar 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 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?
Mean change in logMAR visual acuity at 12 months from baseline. (time frame: 12 months). 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 6 Mar 2012.