Clinical trial NCT00915837: Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Keywords: DME
Lead sponsor: SurModics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: every 3 months for 36 months
Secondary outcomes:
measure: OCT
timeFrame: every 3 months for 36 months
measure: IOP
timeFrame: every 3 months for 36 months
measure: Slit lamp exam/funduscopy
timeFrame: every 3 months for 36 months
measure: Fluorescein angiography
timeFrame: every 3 months for 36 months
measure: Adverse events
timeFrame: every 3 months for 36 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Detroit
country: United States
facility: Kresege Eye Institute
state: Michigan
city: Edina
country: United States
facility: VitreoRetinal Surgery, PA
state: Minnesota
Study officials:
affiliation: VitreoRetinal Surgery, PA
name: Herbert L Cantrill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retinal Consultants of Arizona
name: Pravin U Dugel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kresege Eye Institute
name: Tamer H Mahmoud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: California Retinal Consultants
name: Robert L Avery, MD
role: PRINCIPAL_INVESTIGATOR
References: