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

NCT ID: NCT00915837

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-05-31

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Slow release formulation

Slow release formulation, helical intravitreal triamcinolone implant

Group Type: EXPERIMENTAL

triamcinolone acetonide

Intervention Type: DRUG

Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day

fast release formulation

fast release formulation, helical intravitreal triamcinolone implant

Group Type: EXPERIMENTAL

triamcinolone acetonide

Intervention Type: DRUG

Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day

Interventions

triamcinolone acetonide

Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day

Intervention Type: DRUG

triamcinolone acetonide

Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SurModics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert L Cantrill, MD

Role: PRINCIPAL_INVESTIGATOR

VitreoRetinal Surgery, PA

Pravin U Dugel, MD

Role: PRINCIPAL_INVESTIGATOR

Retinal Consultants of Arizona

Tamer H Mahmoud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kresege Eye Institute

Robert L Avery, MD

Role: PRINCIPAL_INVESTIGATOR

California Retinal Consultants

Locations

Retinal Consultants of Arizona

Phoenix, Arizona, United States

California Retina Consultants

Santa Barbara, California, United States

Kresege Eye Institute

Detroit, Michigan, United States

VitreoRetinal Surgery, PA

Edina, Minnesota, United States

Countries

United States

Other Identifiers

SRDX- 001

Identifier Type: -

Identifier Source: org_study_id