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

Maculopathy, Age-Related Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211419
• Other study ID #: Double Injection
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: October 23, 2012

Study information

• Verified date: September 2005
• Source: Manhattan Eye, Ear & Throat Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Maculopathy, Age-Related
• Wet Macular Degeneration

Intervention

Drug:
• Anecortave Acetate 15 mg

• Triamcinolone Acetate 4 mg

Procedure:
• Photodynamic Therapy with Verteporfin

• Thermal Laser

Locations

Country	Name	City	State
United States	Manhattan Eye, Ear & Throat Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Eye, Ear & Throat Hospital	Alcon Research

Country where clinical trial is conducted

United States,