Maculopathy, Age-RelatedPhase 1NCT00211419
Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
A Phase 1 study testing Anecortave Acetate 15 mg, Triamcinolone Acetate 4 mg and Photodynamic Therapy with Verteporfin in people with Maculopathy, Age-Related, run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of combining juxtasclerally administered anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally following photodynamic therapy with verteporfin for the treatment of 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
- Maculopathy, Age-Related
- What is being tested?
- Anecortave Acetate 15 mg, Triamcinolone Acetate 4 mg and Photodynamic Therapy with Verteporfin
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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
- A male or female with evidence of exudative age-related macular degeneration with clinical/angiographic/optical coherence tomography (OCT) findings of subfoveal choroidal neovascularization (CNV) which has not responded to current therapy
- Baseline best-corrected visual acuity (BCVA) 20/40 to 20/640
- Patient must be willing and able to comply with the protocol and provide informed consent.
Who cannot join
- Patients on intravenous, subcutaneous, or anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5 day holiday from therapy prior to the injection procedure. Note: Patients on oral anticoagulant therapy may be considered to participate if the physician responsible for monitoring the anticoagulant therapy agrees that the patient may take a 5 day holiday from therapy prior to each anecortave injection. The attending doctor must notify the principal investigator and this notification will be made part of the source documentation. Anticoagulant therapy may resume either the evening of or the morning after the injection procedure.
- Patient with known glaucoma or steroid induced ocular hypertension
- Intraocular pressures of 21 mmHg or greater at time of entry into the study
- 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 or capsulotomy within last month in study eye
- Patient participating in any other investigational drug study
Show all 13Show fewer
- Inability to obtain photographs to document CNV (including difficulty with venous access)
- Concomitant oral steroids or topical ophthalmic steroid use
- Sub-Tenon's injection of steroids within the past 6 months
- Patient with significant liver disease or uremia
- Patient with known adverse reaction to indocyanine green, iodine, verteporfin, or triamcinolone
- Patient is pregnant or nursing
- Age less than 50 years old
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
Official title: Pilot Study of the Combination of Anecortave Acetate 15mg Delivered by Posterior Juxtascleral Injection and Triamcinolone Acetonide 4mg Delivered by Intravitreal Injection for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
The purpose of this study is to evaluate the safety of combining juxtasclerally administered anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally following photodynamic therapy with verteporfin for the treatment of exudative age-related macular degeneration (AMD).
- Conditions
- Maculopathy, Age-Related
- Being tested
- Anecortave Acetate 15 mg, Triamcinolone Acetate 4 mg, Photodynamic Therapy with Verteporfin, Thermal Laser
- Keywords
- Exudative 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 15 mgDrug
Triamcinolone Acetate 4 mgDrug
Photodynamic Therapy with VerteporfinProcedure or surgery
Thermal LaserProcedure or surgery
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maculopathy, Age-RelatedStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
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
- NCT00211419
- Sponsor's protocol ID
- Double Injection
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 24 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Combination of Anecortave Acetate 15mg Delivered by Posterior Juxtascleral Injection and Triamcinolone Acetonide 4mg Delivered by Intravitreal Injection for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00211419
- Acronym / sponsor ID
- Double Injection
- Conditions
- Maculopathy, Age-Related
- Keywords
- Exudative Age-Related Macular Degeneration, AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Manhattan Eye, Ear & Throat HospitalUniversity, hospital or other
- Collaborators
- Alcon Research
- 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.
The purpose of this study is to evaluate the safety of combining juxtasclerally administered anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally following photodynamic therapy with verteporfin for the treatment of exudative age-related macular degeneration (AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A male or female with evidence of exudative age-related macular degeneration with clinical/angiographic/optical coherence tomography (OCT) findings of subfoveal choroidal neovascularization (CNV) which has not responded to current therapy
- Baseline best-corrected visual acuity (BCVA) 20/40 to 20/640
- Patient must be willing and able to comply with the protocol and provide informed consent.
Key exclusion criteria (13 listed)
- Patients on intravenous, subcutaneous, or anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5 day holiday from therapy prior to the injection procedure. Note: Patients on oral anticoagulant therapy may be considered to participate if the physician responsible for monitoring the anticoagulant therapy agrees that the patient may take a 5 day holiday from therapy prior to each anecortave injection. The attending doctor must notify the principal investigator and this notification will be made part of the source documentation. Anticoagulant therapy may resume either the evening of or the morning after the injection procedure.
- Patient with known glaucoma or steroid induced ocular hypertension
- Intraocular pressures of 21 mmHg or greater at time of entry into the study
- 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 or capsulotomy within last month in study eye
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 | Drug | – |
| Triamcinolone Acetate 4 mg | Drug | – |
| Photodynamic Therapy with Verteporfin | Procedure or surgery | – |
| Thermal Laser | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 24 Oct 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.
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 1 study testing Anecortave Acetate 15 mg, Triamcinolone Acetate 4 mg and Photodynamic Therapy with Verteporfin in people with Maculopathy, Age-Related, 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 3 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 24 Oct 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 24 Oct 2012.