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Topical Treatment of Uveitic Macular Edema

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uveitis; Cystoid Macular Edema

Intervention: Difluprednate 0.05% ophthalmic emulsion (Drug); Nepafenac 0.1% ophthalmic solution (Drug); Prednisolone acetate 1% ophthalmic suspension (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Nisha Acharya, MD MS, Principal Investigator, Affiliation: University of California, San Francisco

Overall contact:
Erica Browne, MS, Phone: 415-502-2691, Email: erica.browne@ucsf.edu

Summary

Cystoid macular edema is a condition in which there is swelling in the macula, the part of the retina that gives you your best vision. This swelling can cause your vision to get bad. When it is diagnosed early and treated, you vision usually can be preserved. However, if the swelling goes untreated for several months, it can cause permanent vision loss. We think that the two eyedrop regimens in this study, difluprednate or nepafenac plus prednisolone, might be effective in treating uveitic macular edema. Patients who enter this study are being randomized to one of the two regimens and are being followed for one month.

Clinical Details

Official title: Difluprednate Versus Nepafenac Plus Prednisolone Acetate for the Treatment of Cystoid Macular Edema Associated With Uveitis

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

Primary outcome: Number of patients with improvement and/or resolution of macular edema

Secondary outcome:

number of patients with resolution of macular edema

number of patients with improvement in macular edema defined as 20% or greater reduction in central subfield thickness by OCT but not resolution

number of patients with intraocular pressure increase greater than 10mmHg over baseline

Number of patients in each group with 2-line improvement in visual acuity

Change in macular central subfield thickness by OCT at 2 weeks

Detailed description: Randomized, observer-masked superiority trial of difluprednate 0. 05% versus nepafenac 0. 1% plus prednisolone acetate 1%. Patients will be randomized at enrollment to either difluprednate 0. 05% 6 times a day or prednisolone acetate 1% 6 times a day plus nepafenac 0. 1% 3 times a day for 1 month. They will undergo repeat examination at 2 weeks post-enrollment (range 12 to 16 days) and at 4 weeks post-enrollment (range 25-35 days). The OCT, visual acuity and intraocular pressure examiner will be masked as to the patient's assignment. The treating physician and patient will be unmasked.

Eligibility

Minimum age: 7 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- cystoid macular edema secondary to anterior, intermediate, posterior or pan uveitis

Exclusion Criteria:

- Patients taking more than 10mg of oral prednisone a day

- Patient has undergone Retisert placement within the past 3 years

- Patient has undergone intravitreal or peribulbar injection of steroid within the past

3 months

- Patient has undergone Ozurdex injection within the past 3 months

- Patients with posterior uveitis and active inflammation

- Patients who are pregnant, planning on becoming pregnant during the study period or

who are breastfeeding.

- Patients who are taking difluprednate or nepafenac at the beginning of the study

- Patients with infectious uveitis who are not being treated for the infectious cause

- Patients with advanced glaucoma or a cup-to-disc ratio of 0. 9 or greater who do not

have a functioning glaucoma surgery

- Patients with infectious uveitis who are not receiving treatment for the infection or

who have not already been treated.

- Patients who have media opacities that prevent optical coherence tomography imaging.

- Patients with an allergy to any of the components of the drugs used in this study.

- Uncontrolled inflammation in patients with pan or posterior uveitis

Locations and Contacts

Erica Browne, MS, Phone: 415-502-2691, Email: erica.browne@ucsf.edu

University of California, San Francisco F.I. Proctor Foundation, San Francisco, California 94122, United States; Not yet recruiting
Nisha Acharya, Phone: 415-476-8131, Email: nisha.acharya@ucsf.edu
Nisha Acharya, MD MS, Principal Investigator
Additional Information

Starting date: December 2015
Last updated: May 26, 2015

Page last updated: August 23, 2015

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