Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    triamcinolone ...
  • Study Participants

    31
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.
The Helical Intravitreal Triamcinolone Implant is intended to provide sustained release of triamcinolone acetonide into the vitreous chamber of the eye.
Study Started
Jun 30
2005
Primary Completion
Apr 30
2009
Study Completion
May 31
2009
Last Update
Jun 08
2009
Estimate

Drug triamcinolone acetonide

Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day

Drug triamcinolone acetonide

Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day

Slow release formulation Experimental

Slow release formulation, helical intravitreal triamcinolone implant

fast release formulation Experimental

fast release formulation, helical intravitreal triamcinolone implant

Criteria

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
No Results Posted