Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema - Full Text View

Sponsored by:	SurModics, Inc.
Information provided by:	SurModics, Inc.
ClinicalTrials.gov Identifier:	NCT00915837

Purpose

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.

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: triamcinolone acetonide	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by SurModics, Inc.:

Primary Outcome Measures:

Best Corrected Visual Acuity [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

OCT [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: No ]
IOP [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: Yes ]
Slit lamp exam/funduscopy [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: No ]
Fluorescein angiography [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: every 3 months for 36 months ] [ Designated as safety issue: Yes ]

Enrollment:	31
Study Start Date:	June 2005
Study Completion Date:	May 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Slow release formulation: Experimental Slow release formulation, helical intravitreal triamcinolone implant	Drug: triamcinolone acetonide Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day
fast release formulation: Experimental fast release formulation, helical intravitreal triamcinolone implant	Drug: triamcinolone acetonide Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915837

Locations

United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
United States, California
California Retina Consultants
Santa Barbara, California, United States, 93103
United States, Michigan
Kresege Eye Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
VitreoRetinal Surgery, PA
Edina, Minnesota, United States, 55435

Sponsors and Collaborators

SurModics, Inc.

Investigators

Principal Investigator:	Herbert L Cantrill, MD	VitreoRetinal Surgery, PA
Principal Investigator:	Pravin U Dugel, MD	Retinal Consultants of Arizona
Principal Investigator:	Tamer H Mahmoud, MD, PhD	Kresege Eye Institute
Principal Investigator:	Robert L Avery, MD	California Retinal Consultants

More Information

No publications provided

Responsible Party:	SurModics, Inc. ( Shawn Fuller/ Director-Regulatory, Clinical & Quality Compliance )
Study ID Numbers:	SRDX- 001
Study First Received:	June 4, 2009
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00915837 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by SurModics, Inc.:

DME

Study placed in the following topic categories:

Anti-Inflammatory Agents
Immunologic Factors
Hormone Antagonists
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Macular Degeneration
Retinal Degeneration
Triamcinolone diacetate

Immunosuppressive Agents
Hormones
Glucocorticoids
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Triamcinolone
Retinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Macular Degeneration
Retinal Degeneration
Enzyme Inhibitors
Triamcinolone diacetate

Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone
Retinal Diseases

ClinicalTrials.gov processed this record on September 03, 2009