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Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema

NCT00915837 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-06-09

No results posted yet for this study

Summary

This Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema over a three-year period.

Conditions

Interventions

DRUG

triamcinolone acetonide

Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day

DRUG

triamcinolone acetonide

Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day

Sponsors & Collaborators

  • SurModics, Inc.

    lead INDUSTRY

Principal Investigators

  • Herbert L Cantrill, MD · VitreoRetinal Surgery, PA

  • Pravin U Dugel, MD · Retinal Consultants of Arizona

  • Tamer H Mahmoud, MD, PhD · Kresege Eye Institute

  • Robert L Avery, MD · California Retinal Consultants

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00915837 on ClinicalTrials.gov