Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
- Conditions
- UveitisMacular Edema
- Interventions
- Registration Number
- NCT01939691
- Lead Sponsor
- University of California, San Francisco
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nepafenac plus Prednisolone acetate Nepafenac Nepafenac 0.1% 3 times a day until resolution; prednisolone acetate 1% 4 times a day until Week 4, then decrease according to protocol (if resolution of edema at Week 4, decrease to 1 drop per day until Week 6, then stop; if not resolved, continue at 4 times a day until Week 6, then decrease to 1 drop per day until Week 8, then stop). If macular edema not resolved (or reoccurs) by Week 8, treat per best medical judgement. Difluprednate Difluprednate Difluprednate 0.05% ophthalmic emulsion 4 times a day until Week 4, then decrease according to protocol (if resolution of edema at 4 weeks, decrease to 1 drop per day until Week 6, then stop; if not resolved, continue at 4 times a day until 6 weeks and then decrease to 1 drop per day until Week 8 if resolved, then stop). If macular edema not resolved (or reoccurs) by Week 8, treat per best medical judgement. Difluprednate plus Nepafenac Difluprednate Nepafenac 0.1% 3 times a day until resolution; Difluprednate 0.05% ophthalmic emulsion 4 times a day until Week 4, then decrease according to protocol (if resolution of edema at 4 weeks, decrease to 1 drop per day until Week 6, then stop; if not resolved, continue at 4 times a day until 6 weeks and then decrease to 1 drop per day until Week 8 if resolved, then stop). If macular edema not resolved (or reoccurs) by Week 8, treat per best medical judgement. Difluprednate plus Nepafenac Nepafenac Nepafenac 0.1% 3 times a day until resolution; Difluprednate 0.05% ophthalmic emulsion 4 times a day until Week 4, then decrease according to protocol (if resolution of edema at 4 weeks, decrease to 1 drop per day until Week 6, then stop; if not resolved, continue at 4 times a day until 6 weeks and then decrease to 1 drop per day until Week 8 if resolved, then stop). If macular edema not resolved (or reoccurs) by Week 8, treat per best medical judgement. Nepafenac plus Prednisolone acetate Prednisolone acetate Nepafenac 0.1% 3 times a day until resolution; prednisolone acetate 1% 4 times a day until Week 4, then decrease according to protocol (if resolution of edema at Week 4, decrease to 1 drop per day until Week 6, then stop; if not resolved, continue at 4 times a day until Week 6, then decrease to 1 drop per day until Week 8, then stop). If macular edema not resolved (or reoccurs) by Week 8, treat per best medical judgement.
- Primary Outcome Measures
Name Time Method Central subfield thickness 4 weeks Central subfield thickness measured by spectral domain optical coherence tomography adjusting for baseline thickness
- Secondary Outcome Measures
Name Time Method Resolution 4 weeks proportion of patients with resolution of macular edema
Improvement 4 weeks proportion of patients with improvement in macular edema defined as 20% or greater reduction in central subfield thickness by OCT or resolution of edema
recurrence 4 weeks proportion of patients with recurrence of macular edema defined as greater than 20% increase in central subfield thickness to a value \>320 microns by OCT or presence of cysts in an eye that previously had resolution of macular edema
Intraocular pressure (IOP) increase 4 weeks number of patients with intraocular pressure increase at least 10mmHg over baseline
High IOP 4 weeks Number of patients experiencing high intraocular pressure (\> 24 mmHg)
Visual acuity 4 weeks best-corrected visual acuity (ETDRS protocol)
Trial Locations
- Locations (1)
Aravind Eye Hospital
🇮🇳Pondicherry, Tamil Nadu, India