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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00915837
Recruitment Status : Completed
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
Information provided by:
SurModics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: triamcinolone acetonide Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: every 3 months for 36 months ]

Secondary Outcome Measures :
  1. OCT [ Time Frame: every 3 months for 36 months ]
  2. IOP [ Time Frame: every 3 months for 36 months ]
  3. Slit lamp exam/funduscopy [ Time Frame: every 3 months for 36 months ]
  4. Fluorescein angiography [ Time Frame: every 3 months for 36 months ]
  5. Adverse events [ Time Frame: every 3 months for 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915837

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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.
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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
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Responsible Party: Shawn Fuller/ Director-Regulatory, Clinical & Quality Compliance, SurModics, Inc.
ClinicalTrials.gov Identifier: NCT00915837    
Other Study ID Numbers: SRDX- 001
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: June 8, 2009
Last Verified: June 2009
Keywords provided by SurModics, Inc.:
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action