Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
This study has been completed.
Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborator:
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00211419
First received: September 13, 2005
Last updated: October 23, 2012
Last verified: September 2005
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | 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 Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Triamcinolone diacetate
Triamcinolone acetonide
Triamcinolone
Triamcinolone hexacetonide
Verteporfin
U.S. FDA Resources
Further study details as provided by Manhattan Eye, Ear & Throat Hospital:
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211419
Locations
| United States, New York | |
| Manhattan Eye, Ear & Throat Hospital | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
Alcon Research
Investigators
| Principal Investigator: | Jason S Slakter, MD | Manhattan Eye, Ear & Throat Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00211419 History of Changes |
| Other Study ID Numbers: | Double Injection |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Manhattan Eye, Ear & Throat Hospital:
|
Exudative Age-Related Macular Degeneration AMD |
Additional relevant MeSH terms:
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Verteporfin Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Photosensitizing Agents Radiation-Sensitizing Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013