We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00211419
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 24, 2012
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital

Brief 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).

Condition or disease Intervention/treatment 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  (Clinical Trial)
Allocation: Non-Randomized
Masking: None (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)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211419

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
Principal Investigator: Jason S Slakter, MD Manhattan Eye, Ear & Throat Hospital

ClinicalTrials.gov Identifier: NCT00211419     History of Changes
Other Study ID Numbers: Double Injection
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: September 2005

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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents