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Trial record 2 of 6 for:    Durezol | Uveitis

Macular Edema Nepafenac vs. Difluprednate Uveitis Trial (MEND)

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ClinicalTrials.gov Identifier: NCT01939691
Recruitment Status : Recruiting
First Posted : September 11, 2013
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Aravind Eye Hospitals, India
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE September 12, 2018
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
Central subfield thickness [ Time Frame: 4 weeks ]
Central subfield thickness measured by spectral domain optical coherence tomography adjusting for baseline thickness
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
Change in macular central subfield thickness by optical coherence tomography (OCT) [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Resolution [ Time Frame: 4 weeks ]
    proportion of patients with resolution of macular edema
  • Improvement [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 weeks ]
    number of patients with intraocular pressure increase at least 10mmHg over baseline
  • High IOP [ Time Frame: 4 weeks ]
    Number of patients experiencing high intraocular pressure (> 24 mmHg)
  • Visual acuity [ Time Frame: 4 weeks ]
    best-corrected visual acuity (ETDRS protocol)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
  • number of patients with resolution of macular edema [ Time Frame: 1 month ]
  • number of patients with improvement in macular edema defined as 20% or greater reduction in central subfield thickness by OCT but not resolution [ Time Frame: 1 month ]
  • number of patients with intraocular pressure increase greater than 10mmHg over baseline [ Time Frame: 1 month ]
  • Number of patients in each group with 2-line improvement in visual acuity [ Time Frame: 1 month ]
  • Change in macular central subfield thickness by OCT at 2 weeks [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
Official Title  ICMJE Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized 3 arm (1:1:1) parallel design comparative effectiveness trial
Masking: Single (Outcomes Assessor)
Masking Description:
Masked outcome assessment (evaluation of OCT and visual acuity)
Primary Purpose: Treatment
Condition  ICMJE
  • Uveitis
  • Macular Edema
Intervention  ICMJE
  • Drug: Difluprednate
    Difluprednate 0.05% - corticosteroid eyedrop
    Other Name: Durezol
  • Drug: Nepafenac
    Nepafenac 0.1% - NSAID eyedrop
    Other Name: Nevanac
  • Drug: Prednisolone acetate
    prednisolone acetate 1% - corticosteroid eyedrop
    Other Name: Pred Forte, Econo Pred
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Difluprednate
  • Experimental: Nepafenac plus 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.
    Interventions:
    • Drug: Nepafenac
    • Drug: Prednisolone acetate
  • Experimental: Difluprednate plus 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.
    Interventions:
    • Drug: Difluprednate
    • Drug: Nepafenac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2018)
108
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2013)
24
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

108 patients with uveitic ME will be enrolled at Aravind Eye Hospital in Madurai, India based on the following eligibility criteria:

Patient-level Inclusion criteria:

  • ≥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

Eye-level Inclusion Criteria

  • 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

Patient-level Exclusion Criteria

  • 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

Eye-level Exclusion Criteria

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nisha Acharya, MD MS 415-476-8131 nisha.acharya@ucsf.edu
Listed Location Countries  ICMJE India
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01939691
Other Study ID Numbers  ICMJE 18-24978
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Aravind Eye Hospitals, India
Investigators  ICMJE
Principal Investigator: Nisha Acharya, MD MS University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP