CClinicalTrials.gg
CompletedNCT00211484Updated May 7, 2007

Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.

A Phase 2 interventional study of Anecortave Acetate in Age-Related Macular Degenerations. and Subfoveal Neovascularization., sponsored by Manhattan Eye, Ear & Throat Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-05-07.

Sponsored by Manhattan Eye, Ear & Throat Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Age-Related Macular Degenerations.
  • Subfoveal Neovascularization.
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 5 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Manhattan Eye, Ear & Throat Hospital is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  1. Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser).
  2. Patients must be 18 years of age or older to receive treatment.
  3. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
  4. Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

Exclusion criteria

Exclusion Criteria:

  1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
  2. Patients who have undergone intraocular surgery within last 2 months.
  3. Patient participating in any other investigational drug study.
  4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
  5. Inability to obtain photographs to document CNV (including difficulty with venous access).
  6. Patient with significant liver disease or uremia.
  7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
  8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study.
  9. Patient has had insertion of scleral buckle in the study eye.
  10. Patient has received radiation treatment.
  11. Patient is on anticoagulant therapy with the exception of aspirin.
  12. Patient is pregnant or nursing.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Interventions

  • DrugAnecortave Acetate
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. mean change in VA(ETDRS), OCT, FA from baseline to 24 months

    Time frame: 24 months

07

Study locations

1 site
  • Manhattan Eye, Ear & Throat Hospital
    New York, New York 10021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00211484
Lead sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research
First posted
Sep 21, 2005
Start date
May 2003
Completion
Mar 2007
Last update
May 7, 2007

Study contacts

Jason S. Slakter, MD
principal investigator · Manhattan Eye, Ear & Throat Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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