Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00211419
First received: September 13, 2005
Last updated: October 23, 2012
Last verified: September 2005

September 13, 2005
October 23, 2012
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Complete list of historical versions of study NCT00211419 on ClinicalTrials.gov Archive Site
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Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
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).

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Interventional
Phase 1
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Maculopathy, Age-Related
  • Drug: Anecortave Acetate 15 mg
  • Drug: Triamcinolone Acetate 4 mg
  • Procedure: Photodynamic Therapy with Verteporfin
  • Procedure: Thermal Laser
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  1. 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
  2. Baseline best-corrected visual acuity (BCVA) 20/40 to 20/640
  3. Patient must be willing and able to comply with the protocol and provide informed consent.

Exclusion Criteria:

  1. 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.
  2. Patient with known glaucoma or steroid induced ocular hypertension
  3. Intraocular pressures of 21 mmHg or greater at time of entry into the study
  4. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions
  5. Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye
  6. Patient participating in any other investigational drug study
  7. Inability to obtain photographs to document CNV (including difficulty with venous access)
  8. Concomitant oral steroids or topical ophthalmic steroid use
  9. Sub-Tenon's injection of steroids within the past 6 months
  10. Patient with significant liver disease or uremia
  11. Patient with known adverse reaction to indocyanine green, iodine, verteporfin, or triamcinolone
  12. Patient is pregnant or nursing
  13. Age less than 50 years old
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211419
Double Injection
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Manhattan Eye, Ear & Throat Hospital
Alcon Research
Principal Investigator: Jason S Slakter, MD Manhattan Eye, Ear & Throat Hospital
Manhattan Eye, Ear & Throat Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP