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
  Purpose

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).


Condition Intervention Phase
Maculopathy, Age-Related
Drug: Anecortave Acetate 15 mg
Drug: Triamcinolone Acetate 4 mg
Procedure: Photodynamic Therapy with Verteporfin
Procedure: Thermal Laser
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Manhattan Eye, Ear & Throat Hospital:

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211419

Locations
United States, New York
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
Alcon Research
Investigators
Principal Investigator: Jason S Slakter, MD Manhattan Eye, Ear & Throat Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211419     History of Changes
Other Study ID Numbers: Double Injection
Study First Received: September 13, 2005
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Manhattan Eye, Ear & Throat Hospital:
Exudative Age-Related Macular Degeneration
AMD

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Verteporfin
Anecortave
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014