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

Diabetic Macular Edema Clinical Trial

— STRIDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915837
• Other study ID #: SRDX- 001
• Status: Completed
• Phase: Phase 1
• Start date: June 2005
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: SurModics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• triamcinolone acetonide
Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day
• triamcinolone acetonide
Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day

Locations

Country	Name	City	State
United States	Kresege Eye Institute	Detroit	Michigan
United States	VitreoRetinal Surgery, PA	Edina	Minnesota
United States	Retinal Consultants of Arizona	Phoenix	Arizona
United States	California Retina Consultants	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
SurModics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity		every 3 months for 36 months
Secondary	OCT		every 3 months for 36 months
Secondary	IOP		every 3 months for 36 months
Secondary	Slit lamp exam/funduscopy		every 3 months for 36 months
Secondary	Fluorescein angiography		every 3 months for 36 months
Secondary	Adverse events		every 3 months for 36 months