MedDataX Logo

Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD

NCT ID: NCT00065728

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Degeneration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

AMD age-related macular degeneration Anecortave Acetate Wet form of age-related macular degeneration CNV Anecortave Acetate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anecortave Acetate, 15 mg

One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months

Group Type EXPERIMENTAL

Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL

Intervention Type DRUG

One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL

One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Terry Wiernas, PhD

Role: STUDY_DIRECTOR

Alcon Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK

Central Contact Fort Worth, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-03-15

Identifier Type: -

Identifier Source: org_study_id