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A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD

NCT00536016 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-09-21

No results posted yet for this study

Summary

The purpose of this study is to determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye. Repeated dosages will also be given to determine the highest safe dose.

Conditions

  • Macular Degeneration

Interventions

DRUG

JSM6427

Weekly intravitreal injections for up to 4 weeks, first dose strength is one dose below the MTD. Dose strength concentrations: 1.5 mg/ml, 3 mg/ml, 7.5 mg/ml 04 15 mg/ml.

Sponsors & Collaborators

  • Jerini Ophthalmic

    lead INDUSTRY

Principal Investigators

  • Anthony Adamis, MD · Jerini Ophthalmic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536016 on ClinicalTrials.gov