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

Information source: SurModics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema

Intervention: triamcinolone acetonide (Drug); triamcinolone acetonide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: SurModics, Inc.

Official(s) and/or principal investigator(s):
Herbert L Cantrill, MD, Principal Investigator, Affiliation: VitreoRetinal Surgery, PA
Pravin U Dugel, MD, Principal Investigator, Affiliation: Retinal Consultants of Arizona
Tamer H Mahmoud, MD, PhD, Principal Investigator, Affiliation: Kresege Eye Institute
Robert L Avery, MD, Principal Investigator, Affiliation: California Retinal Consultants

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Best Corrected Visual Acuity

Secondary outcome:

OCT

IOP

Slit lamp exam/funduscopy

Fluorescein angiography

Adverse events

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Retinal Consultants of Arizona, Phoenix, Arizona 85014, United States

California Retina Consultants, Santa Barbara, California 93103, United States

Kresege Eye Institute, Detroit, Michigan 48201, United States

VitreoRetinal Surgery, PA, Edina, Minnesota 55435, United States

Additional Information

Starting date: June 2005
Last updated: June 4, 2009

Page last updated: August 23, 2015

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