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

Sponsor

Manhattan Eye, Ear & Throat Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00211419

Collaborator

Alcon Research (Industry)

Location

Study Details

Study Description

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 Design

Study Type:

Interventional

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)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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