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

Manhattan Eye, Ear & Throat Hospital

Status and phase: Completed; Phase 1

Conditions: Maculopathy, Age-Related

Treatments: Procedure: Photodynamic Therapy with Verteporfin; Drug: Anecortave Acetate 15 mg; Procedure: Thermal Laser; Drug: Triamcinolone Acetate 4 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00211419

Double Injection

Details and patient eligibility

About

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).

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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