Status:
COMPLETED
Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema
Lead Sponsor:
SurModics, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Patients with clinically observable macular edema associated with diabetic retinopathy in study eye
- Macular edema in study eye is associated with
- visual acuity of 20/40 or worse; and
- retinal thickening in the fovea as seen on biomicroscopic examination
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00915837
Start Date
June 1 2005
End Date
May 1 2009
Last Update
June 9 2023
Active Locations (4)
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1
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
2
California Retina Consultants
Santa Barbara, California, United States, 93103
3
Kresege Eye Institute
Detroit, Michigan, United States, 48201
4
VitreoRetinal Surgery, PA
Edina, Minnesota, United States, 55435