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

This study has been completed.
Sponsor:
Information provided by:
SurModics, Inc.
ClinicalTrials.gov Identifier:
NCT00915837
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Drug: triamcinolone acetonide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Prospective, Randomized, Double-Masked, Multicenter Study to Evaluate the Safety and Tolerability of Two Dose Levels of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by SurModics, Inc.:

Primary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OCT [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: Yes ]
  • Slit lamp exam/funduscopy [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: No ]
  • Fluorescein angiography [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: June 2005
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Slow release formulation
Slow release formulation, helical intravitreal triamcinolone implant
Drug: triamcinolone acetonide
Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day
Experimental: fast release formulation
fast release formulation, helical intravitreal triamcinolone implant
Drug: triamcinolone acetonide
Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day

Detailed Description:

The Helical Intravitreal Triamcinolone Implant is intended to provide sustained release of triamcinolone acetonide into the vitreous chamber of the eye.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinically observable macular edema associated with diabetic retinopathy in study eye
  • Macular edema in study eye is associated with

    1. visual acuity of 20/40 or worse; and
    2. retinal thickening in the fovea as seen on biomicroscopic examination
    3. angiographic evidence of leakage involving the perifoveal capillary net
  • Failure of macular edema to improve with prior macular photocoagulation, or the patient is unlikely to benefit from macular photocoagulation in the opinion of the investigator
  • Patients must be 18 years of age and older
  • Patients must be willing and able to return for scheduled follow up examinations for 3 years after initial surgery.
  • Patients must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

  • Monocular, or vision worse than 20/400 in the fellow eye
  • Visual acuity worse than 20/200 20/200 and < 34 letters read in the study eye
  • Use of depot periocular steroids in the study eye within the past 30 days
  • Current use of >15 mg/day of oral steroids
  • Known steroid responder
  • Ocular hypertension > 22 mmHg in the study eye or need for more than one medication to maintain IOP < 22 mmHg.
  • Cup to disc ratio of > 0.8 in the study eye
  • Prior filtration surgery or glaucoma implant surgery in the study eye
  • Any active ocular infection in either eye
  • History of herpetic ocular infection in the study eye
  • Macular ischemia, defined as angiographic evidence of enlargement of the foveal avascular zone to 1 disc area or larger, centered on the fovea
  • Macular or panretinal photocoagulation treatment in the study eye within the past 90 days; laser capsulotomy within the past 90 days
  • Planned or known need for ocular surgery in the study eye within 90 days after enrollment and treatment
  • Any condition that precludes the subject's ability to comply with study requirements, including examinations or the completion of the study; or any condition that precludes the examiner's ability to obtain reliable fundus photography, angiography, or OCT images
  • Females who are pregnant or lactating, and premenopausal females who are unwilling to use a medically accepted method of birth control for the duration of the study
  • Participation in another investigational trial within 30 days prior to enrollment or during the study period
  • Uncontrolled hypertension (systolic BP > 160 mm Hg and/or diastolic BP > 90 mmHg)
  • Uncontrolled diabetes (HbA1c > 13)
  • Chronic renal failure requiring dialysis or anticipated renal transplant
  • Retinal or choroidal neovascularization in the study eye; anticipated need for panretinal photocoagulation within the next 30 days
  • Macular edema in the study eye known to be due to a cause other than diabetic retinopathy
  • Use of immunosuppressant drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915837

Locations
United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
United States, California
California Retina Consultants
Santa Barbara, California, United States, 93103
United States, Michigan
Kresege Eye Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
VitreoRetinal Surgery, PA
Edina, Minnesota, United States, 55435
Sponsors and Collaborators
SurModics, Inc.
Investigators
Principal Investigator: Herbert L Cantrill, MD VitreoRetinal Surgery, PA
Principal Investigator: Pravin U Dugel, MD Retinal Consultants of Arizona
Principal Investigator: Tamer H Mahmoud, MD, PhD Kresege Eye Institute
Principal Investigator: Robert L Avery, MD California Retinal Consultants
  More Information

No publications provided

Responsible Party: Shawn Fuller/ Director-Regulatory, Clinical & Quality Compliance, SurModics, Inc.
ClinicalTrials.gov Identifier: NCT00915837     History of Changes
Other Study ID Numbers: SRDX- 001
Study First Received: June 4, 2009
Last Updated: June 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by SurModics, Inc.:
DME

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014