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

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

Official Title
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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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: triamcinolone acetonide
* Drug: triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow release formulation<br>Slow release formulation, helical intravitreal triamcinolone implant | Drug: triamcinolone acetonide<br>* Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day<br>|
| Experimental: fast release formulation<br>fast release formulation, helical intravitreal triamcinolone implant | Drug: triamcinolone acetonide<br>* Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity |  | every 3 months for 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT |  | every 3 months for 36 months | 
| IOP |  | every 3 months for 36 months | 
| Slit lamp exam/funduscopy |  | every 3 months for 36 months | 
| Fluorescein angiography |  | every 3 months for 36 months | 
| Adverse events |  | every 3 months for 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DME