NCT00346957

Brief Summary

The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 1999

Typical duration for phase_2

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

4 years

First QC Date

June 28, 2006

Last Update Submit

March 3, 2012

Conditions

AMD

Outcome Measures

Primary Outcomes (1)

  • Mean change in logMAR visual acuity at 12 months from baseline.

    12 months

Study Arms (4)

Anecortave Acetate 30

EXPERIMENTAL
Drug: Anecortave acetate 30 mg

Anecortave Acetate 15

EXPERIMENTAL
Drug: Anecortave Acetate 15 mg

Anecortave Acetate 3

EXPERIMENTAL
Drug: Anecortave Acetate 3 mg

Anecortave Acetate Vehicle

PLACEBO COMPARATOR
Other: Anecortave Acetate Vehicle

Interventions

Anecortave acetate 30 mgDRUG

0.5ml administered onto the sclera once every six months for 24 months

Anecortave Acetate 30
Anecortave Acetate 15 mgDRUG

0.5ml administered onto the sclera once every six months for 24 months

Anecortave Acetate 15
Anecortave Acetate 3 mgDRUG

0.5ml administered onto the sclera once every six months for 24 months

Anecortave Acetate 3
Anecortave Acetate VehicleOTHER

0.5ml administered onto the sclera once every six months for 24 months

Anecortave Acetate Vehicle

Eligibility Criteria

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

You may qualify if:

  • Ages 50 years and over

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

anecortave acetate

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2006

First Posted

July 4, 2006

Study Start

April 1, 1999

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

March 6, 2012

Record last verified: 2012-03