A Study of MK0140 in Diabetic Patients With Macular Edema - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00692614

Purpose

This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema.

Condition	Intervention	Phase
Macular Edema	Drug: triamcinolone acetonide	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIb, Randomized, Masked, Sham-Controlled, Clinical Trial to Study the Efficacy and Safety of the Helical Triamcinolone Acetonide Implant (MK0140) in Diabetic Patients With Clinically Significant Macular Edema

Further study details as provided by Merck:

Primary Outcome Measures:

Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses. [ Time Frame: After 12 months of therapy. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluation of visual acuity; change from baseline in OCT center-point retinal thickness; the need for focal/grid laser photocoagulation during the study; the progression of diabetic retinopathy [ Time Frame: After 12 months of therapy. ] [ Designated as safety issue: No ]

Enrollment:	2
Study Start Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 100 mcg triamcinolone acetonide	Drug: triamcinolone acetonide 100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
2: Experimental 500 mcg triamcinolone acetonide	Drug: triamcinolone acetonide 100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
3: Experimental 925 mcg triamcinolone acetonide	Drug: triamcinolone acetonide 100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
4: No Intervention sham control - not implanted, no medication

Eligibility

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

Criteria

Inclusion Criteria:

Patient has clinically significant macular edema as a result of their diabetes (Type I or Type 2)
Patient has in the study eye, 20/40 - 20/160 vision
Patient has Type 1 or Type 2 diabetes
Patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control

Exclusion Criteria:

Patient has had any active ocular infection in either eye
Patient has intraocular pressure > 22 mmHg or a diagnosis of glaucoma
Patient has cystoid macular edema in the study eye
Patient has a history of elevated IOP in response to ocular steroid therapy in either eye
Patient has had intraocular surgery in the study eye within 6 months prior to Visit 1
Patient has an HbAIc value > 10% at Visit 1
Patient has within the last 4 months initiated intensive insulin treatment or plan to do so in the next 4 months
Patient has a history of cancer within 5 years prior to signing informed consent
Patient has clinically-relevant chronic renal failure
Patient has high blood pressure
Patient has coronary heart disease
Patient has known allergies to steroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692614

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_521, MK0140-001
Study First Received:	June 4, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00692614
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Eye Diseases
Triamcinolone
Retinal Degeneration

Macular Degeneration
Edema
Triamcinolone diacetate
Retinal Diseases
Triamcinolone hexacetonide
Retinal degeneration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009