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

October 23, 2012 updated by: Manhattan Eye, Ear & Throat Hospital

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Manhattan Eye, Ear & Throat Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manhattan Eye, Ear & Throat Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason S Slakter, MD, Manhattan Eye, Ear & Throat Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Double Injection

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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