A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00692614
• Other study ID #: 0140-001
• Secondary ID: MK0140-0012008_5
• Status: Terminated
• Phase: Phase 2
• First received: June 4, 2008
• Last updated: October 30, 2015
• Start date: June 2008
• Est. completion date: November 2008

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• triamcinolone acetonide
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.		After 12 months of therapy.	Yes
Secondary	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		After 12 months of therapy.	No