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OpenTrials
Completed

NCT Number: NCT00211419

Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide 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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Manhattan Eye, Ear & Throat Hospital

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Patient with known glaucoma or steroid induced ocular hypertension
  • Intraocular pressures of 21 mmHg or greater at time of entry into the study
  • Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions
  • Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye
  • Patient participating in any other investigational drug study
  • Inability to obtain photographs to document CNV (including difficulty with venous access)
  • Concomitant oral steroids or topical ophthalmic steroid use
  • Sub-Tenon's injection of steroids within the past 6 months
  • Patient with significant liver disease or uremia
  • Patient with known adverse reaction to indocyanine green, iodine, verteporfin, or triamcinolone
  • Patient is pregnant or nursing
  • Age less than 50 years old

Treatment and study plan

Anecortave Acetate 15 mg

Drug

Triamcinolone Acetate 4 mg

Drug

Photodynamic Therapy with Verteporfin

Procedure

Thermal Laser

Procedure

Sponsors and collaborators

Lead sponsor

Manhattan Eye, Ear & Throat Hospital

Other

Collaborators

  • Alcon Research

Registry information

Official study 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)

Important dates

First posted
Sep 21, 2005
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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