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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 October 2012
• Main ID: NCT00211419
• Date of registration: 13/09/2005
• Primary sponsor: Manhattan Eye, Ear & Throat Hospital
• Public title: Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
• Scientific 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)
• Date of first enrolment: May 2005
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00211419
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jason S Slakter, MD
• Affiliation: Manhattan Eye, Ear & Throat Hospital

Key inclusion & exclusion criteria

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



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Maculopathy, Age-Related

Intervention(s)

Drug: Anecortave Acetate 15 mg

Drug: Triamcinolone Acetate 4 mg

Procedure: Photodynamic Therapy with Verteporfin

Procedure: Thermal Laser

Secondary ID(s)

Double Injection

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alcon Research