Study to Treat Uveitis Associated Macular Edema

NCT00114062 | Terminated Phase 2

• 1 other identifier: 06-103
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cystoid Macular Edema; Uveitis

Keywords

uveitis; macular edema; uveitis associated macular edema

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.

• Assess the utility of denufosol in treating uveitis associated macular edema.

Secondary Outcomes (1)

• Pilot study - not specified

Interventions

denufosol tetrasodium (INS37217) Intravitreal Injection DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Macular Edema; Uveitis

Interventions

denufosol tetrasodium; Intravitreal Injections

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Amy Schaberg, BSN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2005
• First Posted: June 14, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 29, 2016

Record last verified: 2016-11