Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
Information source: Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Maculopathy, Age-Related
Intervention: Anecortave Acetate 15 mg (Drug); Triamcinolone Acetate 4 mg (Drug); Photodynamic Therapy with Verteporfin (Procedure); Thermal Laser (Procedure)
Phase: Phase 1
Status: Completed
Sponsored by: Manhattan Eye, Ear & Throat Hospital Official(s) and/or principal investigator(s): Jason S Slakter, MD, Principal Investigator, Affiliation: Manhattan Eye, Ear & Throat Hospital
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).
Clinical Details
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)
Study design: Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Manhattan Eye, Ear & Throat Hospital, New York, New York 10021, United States
Additional Information
Last updated: October 23, 2012
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