Age-Related Macular Degenerations.Phase 2NCT00211484
Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.
A Phase 2 study testing Anecortave Acetate in people with Age-Related Macular Degenerations. and Subfoveal Neovascularization., run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
Trial summary
A compassionate method of treatment is offered to patients where lesions do not meet acceptable criteria for standard therapy. Visudyne (Photodynamic Therapy) and laser photocoagulation treatment (a treatment using heat from a fine point laser beam) have not been found to be effective in treating the lesions these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degenerations., Subfoveal Neovascularization.
- What is being tested?
- Anecortave Acetate
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Mar 2007
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser).
- Patients must be 18 years of age or older to receive treatment.
- Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
- Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart.
Who cannot join
- Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Patients who have undergone intraocular surgery within last 2 months.
- Patient participating in any other investigational drug study.
- Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
- Inability to obtain photographs to document CNV (including difficulty with venous access).
- Patient with significant liver disease or uremia.
Show all 12Show fewer
- Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
- Patient has a history of any medical condition which would preclude scheduled visits or completion of study.
- Patient has had insertion of scleral buckle in the study eye.
- Patient has received radiation treatment.
- Patient is on anticoagulant therapy with the exception of aspirin.
- Patient is pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Eye, Ear & Throat Hospital
New York, New York, 10021
About this study
A compassionate method of treatment is offered to patients where lesions do not meet acceptable criteria for standard therapy. Visudyne (Photodynamic Therapy) and laser photocoagulation treatment (a treatment using heat from a fine point laser beam) have not been found to be effective in treating the lesions these patients have.
Anecortave acetate is an experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD).
Read the detailed description
Patients will receive a sub-Tenon injection of 15mg of Anecortave acetate in their study eye with the use of a counter pressure device. Patients will then be followed for up to 24 months. The patients will have the option of extending their participation in the study for an additional 24 months. Statistical analysis will include comparison of patient follow-up visual acuity and angiographic data.
- Being tested
- Anecortave Acetate
- 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 AcetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
This study is designed to provide compassionate use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients where the lesions do not meet acceptable criteria for standard therapy.
Measured: 24 months
Secondary outcomes (1)
mean change in VA(ETDRS), OCT, FA from baseline to 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2003
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular Degenerations.Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Eye, Ear & Throat Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Jason S. Slakter, MD, Principal investigator, Manhattan Eye, Ear & Throat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211484
- Sponsor's protocol ID
- AA outside standard care
- Status last verified
- May 2007
- First submitted
- 13 Sep 2005
- Last updated
- 7 May 2007
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.
- ClinicalTrials.gov ID
- NCT00211484
- Acronym / sponsor ID
- AA outside standard care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Manhattan Eye, Ear & Throat HospitalUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- May 2003
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Sep 2005 (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.
A compassionate method of treatment is offered to patients where lesions do not meet acceptable criteria for standard therapy. Visudyne (Photodynamic Therapy) and laser photocoagulation treatment (a treatment using heat from a fine point laser beam) have not been found to be effective in treating the lesions these patients have.
Anecortave acetate is an experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD).
Detailed description
Patients will receive a sub-Tenon injection of 15mg of Anecortave acetate in their study eye with the use of a counter pressure device. Patients will then be followed for up to 24 months. The patients will have the option of extending their participation in the study for an additional 24 months. Statistical analysis will include comparison of patient follow-up visual acuity and angiographic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser).
- Patients must be 18 years of age or older to receive treatment.
- Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
- Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart.
Key exclusion criteria (12 listed)
- Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Patients who have undergone intraocular surgery within last 2 months.
- Patient participating in any other investigational drug study.
- Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
- Inability to obtain photographs to document CNV (including difficulty with venous access).
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 | Drug | – |
Primary outcome
This study is designed to provide compassionate use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients where the lesions do not meet acceptable criteria for standard therapy.
Time frame: 24 months
1 secondary outcome
mean change in VA(ETDRS), OCT, FA from baseline to 24 months
Time frame: 24 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 7 May 2007.
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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.
Jason S. Slakter, MD principal investigator
Manhattan Eye, Ear & Throat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anecortave Acetate in people with Age-Related Macular Degenerations. and Subfoveal Neovascularization., run by Manhattan Eye, Ear & Throat Hospital 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 4 inclusion and 12 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 7 May 2007. 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. 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?
This study is designed to provide compassionate use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients where the lesions do not meet acceptable criteria for standard therapy. (time frame: 24 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 7 May 2007.