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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: triamcinolone acetonide; Drug: triamcinolone acetonide

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Retinal Consultants of Arizona
  • California
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Kresege Eye Institute
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • VitreoRetinal Surgery, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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; Drug: triamcinolone acetonide; Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day
Experimental: fast release formulation; fast release formulation, helical intravitreal triamcinolone implant	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Best Corrected Visual Acuity	every 3 months for 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
OCT	every 3 months for 36 months
IOP	every 3 months for 36 months
Slit lamp exam/funduscopy	every 3 months for 36 months
Fluorescein angiography	every 3 months for 36 months
Adverse events	every 3 months for 36 months

Collaborators and Investigators

• Sponsor: SurModics, Inc.
• Investigators: Principal Investigator: Pravin U Dugel, MD, Retinal Consultants of Arizona; Principal Investigator: Herbert L Cantrill, MD, VitreoRetinal Surgery, PA; Principal Investigator: Tamer H Mahmoud, MD, PhD, Kresege Eye Institute; Principal Investigator: Robert L Avery, MD, California Retinal Consultants

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: June 4, 2009
• First Submitted That Met QC Criteria: June 4, 2009
• First Posted (Estimated): June 8, 2009

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: DME
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: SRDX- 001