Macular Edema Nepafenac vs. Difluprednate Uveitis Trial

NCT01939691 | Terminated Phase 4 DMC

• 1 other identifier: 18-24978
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Uveitis; Macular Edema

Keywords

difluprednate; prednisolone acetate; nepafenac

Outcome Measures

Primary Outcomes (1)

• Central subfield thickness

  Central subfield thickness measured by spectral domain optical coherence tomography adjusting for baseline thickness

  4 weeks

Secondary Outcomes (6)

• Resolution

  4 weeks

• Improvement

  4 weeks

• recurrence

  4 weeks

• Intraocular pressure (IOP) increase

  4 weeks

• High IOP

  4 weeks

Study Arms (3)

Difluprednate

EXPERIMENTAL

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.

Drug: Difluprednate

Nepafenac plus Prednisolone acetate

EXPERIMENTAL

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.

Drug: Nepafenac; Drug: Prednisolone acetate

Difluprednate plus Nepafenac

EXPERIMENTAL

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.

Drug: Difluprednate; Drug: Nepafenac

Interventions

Difluprednate DRUG

Difluprednate 0.05% - corticosteroid eyedrop

Also known as: Durezol

Difluprednate; Difluprednate plus Nepafenac

Nepafenac DRUG

Nepafenac 0.1% - NSAID eyedrop

Also known as: Nevanac

Difluprednate plus Nepafenac; Nepafenac plus Prednisolone acetate

Prednisolone acetate DRUG

prednisolone acetate 1% - corticosteroid eyedrop

Also known as: Pred Forte, Econo Pred

Nepafenac plus Prednisolone acetate

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age
• Diagnosis of anterior, intermediate, posterior, or panuveitis (can be infectious or non-infectious)
• Inactive or minimally active inflammation according to Standardization of Uveitis Nomenclature criteria (≤ 0.5+ Anterior Chamber (AC) cells, ≤ 0.5+ vitreous haze and no active retinal/choroidal lesions)
• If on oral corticosteroids, a stable dose of \<10 mg prednisone/day for \>4 weeks
• If on systemic corticosteroid-sparing immunomodulatory therapy, a stable dose for \>4 weeks
• If using prednisolone acetate 1% drops, stable regimen of ≤2 drops per day for \>4 weeks
• If infectious uveitis, inflammation must be inactive or minimally active per definition above and on stable dose of treatment for ≥4 weeks with no anticipated changes to treatment during the trial
• ME defined as thickening of the 1mm central subfield of the macula greater than 2 standard deviations above normal thickness (\>320 µm by Heidelberg spectral-domain OCT) with or without the presence of intraretinal cysts.
• Baseline intraocular pressure \>5 mmHg and \<21 mmHg (current use ≤3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable)
• Media clarity and pupillary dilation sufficient to allow OCT testing and retinal photography
• Best-corrected visual acuity of 5/200 or better

You may not qualify if:

• Use of oral acetazolamide or other systemic carbonic anhydrase inhibitors at baseline
• Known allergy or hypersensitivity to any component of the study drugs
• Women who are pregnant or breastfeeding (pregnancy test should be administered prior to baseline fluorescein angiogram)
• Patients unwilling or unable to not wear contact lenses during the study period
• History of central serous chorioretinopathy in either eye
• Intravitreal or periocular corticosteroid injection in the past 8 weeks, dexamethasone implant in the past 12 months, or a fluocinolone acetonide implant in the past 3 years
• Presence of an epiretinal membrane-noted clinically or by OCT-in the study eye, thought to be significant enough to preclude improvement of ME
• Previous pars plana vitrectomy
• History of severe glaucoma (C/D ratio \> 0.9 or any notching of optic nerve to rim)
• Prior use of difluprednate or nepafenac in the past 4 weeks

Sponsors & Collaborators

• University of California, San Francisco: lead
• Aravind Eye Hospitals, India: collaborator

Study Sites (3)

Aravind Eye Hospital

Coimbatore, Tamil Nadu, India

Location

Aravind Eye Hospital

Madurai, Tamil Nadu, India

Location

Aravind Eye Hospital

Pondicherry, Tamil Nadu, India

Location

MeSH Terms

Conditions

Uveitis; Macular Edema

Interventions

difluprednate; nepafenac; prednisolone acetate

Condition Hierarchy (Ancestors)

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

Study Officials

• Nisha Acharya, MD MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masked outcome assessment (evaluation of OCT and visual acuity)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 3 arm (1:1:1) parallel design comparative effectiveness trial

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 11, 2013
• Study Start: September 12, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)