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

Phase 1

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: triamcinolone acetonide

• Registration Number: NCT00915837
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2009-06
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-08
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fast release formulation	triamcinolone acetonide	fast release formulation, helical intravitreal triamcinolone implant
Slow release formulation	triamcinolone acetonide	Slow release formulation, helical intravitreal triamcinolone implant

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	every 3 months for 36 months

Secondary Outcome Measures

Name	Time	Method
OCT	every 3 months for 36 months
Adverse events	every 3 months for 36 months
Fluorescein angiography	every 3 months for 36 months
IOP	every 3 months for 36 months
Slit lamp exam/funduscopy	every 3 months for 36 months

Trial Locations

Locations (4)

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

California Retina Consultants; 🇺🇸 Santa Barbara, California, United States

VitreoRetinal Surgery, PA; 🇺🇸 Edina, Minnesota, United States

Kresege Eye Institute; 🇺🇸 Detroit, Michigan, United States