Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT01939691
Study type Interventional
Source University of California, San Francisco
Contact
Status Terminated
Phase Phase 4
Start date September 12, 2018
Completion date March 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT04292912 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema Phase 1
Recruiting NCT05976139 - Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies N/A
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT01660802 - Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO) Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04592419 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Completed NCT02623673 - Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema N/A
Terminated NCT01946399 - Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF N/A
Completed NCT01428388 - Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion N/A
Completed NCT01231633 - Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO) N/A
Recruiting NCT01023113 - To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation N/A
Terminated NCT00918554 - Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis Phase 4
Terminated NCT00969293 - Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion Phase 1
Completed NCT00970957 - Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion Phase 3
Completed NCT00476593 - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications N/A
Completed NCT00668239 - Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser N/A
Completed NCT00411970 - 20- Versus 23- Gauge System for Pars Plana Vitrectomy Phase 4
Active, not recruiting NCT04120311 - Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole Phase 1