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TerminatedNCT00211471Updated May 7, 2007

Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.).

A Phase 2 interventional study of anecortave acetate in Severe Diabetic Retinopathy, Central Retinal Vein Occlusion and Chronic Inflammation, sponsored by Manhattan Eye, Ear & Throat Hospital. Terminated 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

Why this study was terminated
poor enrollment
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

To provide use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients with rubeosis iridis. Rubeosis iridis refers to neovascularization of the iris. It is caused by a number of conditions which include, but are not limited to severe diabetic retinopathy, central retinal vein occlusion, chronic inflammation, and infection. Anecortave acetate is an angiostatic, experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD). Therefore, it is logical to apply the usage of Anecortave to patient's with rubeosis iridis in order to reduce the neovascularization stimulus and cause the regression of the abnormal iris vessels.

Read the detailed description

Patients will receive an injection of 15 mg of Anecortave acetate behind the eye to be treated ("study eye"). They will be evaluated every six months to determine if their condition is stable or worse. Following the injection of study medication, patients will not be required to come in to see the study physician. The investigator or study staff will call the patients on the day following injection to make sure there were no adverse effects to the injection. Patients will then come in for a Week 4 and Month 3 follow-up visit. At the Month 3 follow-up visit, if patients are not showing stability or improvement, they may be offered either thermal laser or Photodynamic Therapy. They will remain in the study and remain eligible for a repeat injection of Anecortave Acetate at the Month 6 visit.

Patients will then been seen at Month 6 for a Re-treatment Evaluation Visit. If their condition is stable, they will be offered re-injection with the same study medication they received earlier. If Patients are not showing stability or improvement at the Month 6 visit, they may be offered thermal laser or Photodynamic Therapy in conjunction with the Anecortave Acetate injection.

If the patient is re-injected at the 6 month visit, the schedule of follow-up visits will repeat as before for the next 18 months. If the patient opts out of the re-injection, they will be exited from the study.

02

Conditions studied

  • Severe Diabetic Retinopathy
  • Central Retinal Vein Occlusion
  • Chronic Inflammation
  • Infectious Diseases
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

Browse Communicable Diseases 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
Accepts healthy volunteers
No

Inclusion criteria

  1. Clinical diagnosis of rubeosis iridis in patients with retinal ischemia.
  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 pregnant or nursing.
  12. Patient is on intravenous or subcutaneous anticoagulant therapy, or is on oral anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5-day interruption in therapy prior to each depot or sham administration.
  13. Patient has evidence of scleral thinning seen at the time of external eye exam or at the time of depot or sham administration.
05

Study design

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

Interventions

  • Druganecortave acetate
06

What researchers measure

Primary outcomes

  1. tyo investigate the use of anecortave acetate in rubeosis iridis

    Time frame: 24 months

Secondary outcomes

  1. mean change in VA(ETDRS) 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
NCT00211471
Lead sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research
First posted
Sep 21, 2005
Start date
Mar 2002
Completion
May 2007
Last update
May 7, 2007

Study contacts

Lawrence A. Yannuzzi, 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 terminated, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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