Topical Treatment of Uveitic Macular Edema
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cardiology, Ocular, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2015 |
| End Date: | March 2018 |
| Contact: | Erica Browne, MS |
| Email: | erica.browne@ucsf.edu |
| Phone: | 415-502-2691 |
Difluprednate Versus Nepafenac Plus Prednisolone Acetate for the Treatment of Cystoid Macular Edema Associated With Uveitis
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.
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.
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.
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.
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
We found this trial at
1
site
San Francisco, California 94122
Principal Investigator: Nisha Acharya, MD MS
Phone: 415-476-8131
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