NCT01939691

Macular Edema Nepafenac vs. Difluprednate Uveitis Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 decline. When diagnosed early and treated, you vision usually can be preserved. However, if the swelling goes untreated for a long time, it can cause permanent vision loss. We think that the three eye drop regimens in this study, difluprednate, difluprednate plus nepafenac, and prednisolone acetate plus nepafenac, might be effective in treating uveitic macular edema. Patients who enter this study are randomized to one of the three regimens and followed for 24 weeks.

Detailed description

Trial: Randomized 3 arm (1:1:1) parallel design comparative effectiveness trial Stratification: Systemic corticosteroid/immunosuppressive therapy vs. none Treatments: 1) difluprednate 0.05% 2) combination therapy of prednisolone acetate 1% with nepafenac 0.1% 3) combination therapy of difluprednate 0.05% with nepafenac 0.1% Masking: Unmasked treatment administration; masked outcome assessment (evaluation of OCT and visual acuity) Follow-up: 2, 4, 6, 8, and 24 weeks Treatment protocol: Patients will be randomized at enrollment to either: * difluprednate 0.05% 4 drops per day * prednisolone acetate 1% 4 drops per day and nepafenac 0.1% 3 drops per day * difluprednate 0.05% 4 drops per day and nepafenac 0.1% 3 drops per day If macular edema has not resolved at Week 4, continue study treatment at the same dose until Week 6. If macular edema has resolved at Week 4, reduce study treatment as follows: * difluprednate 0.05% 1 drop per day until Week 6, then stop * prednisolone acetate 1% 1 drop per day and nepafenac 0.1% 3 drops per day until Week 6, then stop * difluprednate 0.05% 1 drop per day and nepafenac 0.1% 3 drops per day until Week 6, then stop If macular edema does not resolve at Week 4 but has resolved at Week 6, reduce study treatment at Week 6 as follows: * difluprednate 0.05% 1 drop per day until Week 8, then stop * prednisolone acetate 1% 1 drop per day and nepafenac 0.1% 3 drops per day until Week 8, then stop * difluprednate 0.05% 1 drop per day and nepafenac 0.1% 3 drops per day until Week 8, then stop If macular edema resolves at Week 4 but reoccurs at Week 6, treat per best medical judgement. After Week 8, there are no restrictions on the treatments patients may receive, and medications can be tapered further, discontinued, or changed at the discretion of the treating physician and patient preference. If a patient with previously resolved macular edema has a recurrence, the physician may treat according to best medical judgement.

Conditions

• Uveitis
• Macular Edema

Interventions

Type	Name	Description
DRUG	Difluprednate	Difluprednate 0.05% - corticosteroid eyedrop
DRUG	Nepafenac	Nepafenac 0.1% - NSAID eyedrop
DRUG	Prednisolone acetate	prednisolone acetate 1% - corticosteroid eyedrop

Timeline

• Start date: 2018-09-12
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2013-09-11
• Last updated: 2021-01-13

Locations

3 sites across 1 country: India