Study to Treat Uveitis Associated Macular Edema

Uveitis Clinical Trial

Official title:

A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Uveitis Associated Macular Edema

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00114062
• Other study ID #: 06-103
• Status: Terminated
• Phase: Phase 2
• First received: June 13, 2005
• Last updated: November 28, 2016
• Start date: September 2005
• Est. completion date: December 2006

Study information

• Verified date: November 2016
• 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

The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.

Description:

Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse the fluid accumulation of UME.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye

• Have persistent macular edema and uveitis whose conditions are stable

• Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected)

• Have an OCT scan with a qualifying retinal thickness in the study eye

• Have evidence of macular edema on OCT scan

• Have at lease one eligible eye to be treated in the study based on visual acuity.

Exclusion Criteria:

• Have proliferative vitreoretinopathy greater than grade B

• Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA

• Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye

• Have ocular disorders in the study eye that may confound interpretation of study results

• Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days

• Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye

• Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening

• Have any ocular implant device for the delivery of therapeutic agents to the eye

• Be taking any excluded medications that could obscure or confound study results

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystoid Macular Edema
• Edema
• Macular Edema
• Uveitis

Intervention

Drug:
• denufosol tetrasodium (INS37217) Intravitreal Injection

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	Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
Primary	Assess the utility of denufosol in treating uveitis associated macular edema.
Secondary	Pilot study - not specified