NCT00211419

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 24, 2012

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

October 23, 2012

Conditions

Maculopathy, Age-Related

Keywords

Exudative Age-Related Macular DegenerationAMD

Interventions

Anecortave Acetate 15 mgDRUG
Triamcinolone Acetate 4 mgDRUG
Photodynamic Therapy with VerteporfinPROCEDURE
Thermal LaserPROCEDURE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Eye, Ear & Throat Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

anecortave acetateTriamcinolonePhotochemotherapyVerteporfin

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCombined Modality TherapyTherapeuticsDrug TherapyPhototherapyPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic Compounds

Study Officials

  • Jason S Slakter, MD

    Manhattan Eye, Ear & Throat Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Last Updated

October 24, 2012

Record last verified: 2005-09

Locations

US(1)