Your session is about to expire
← Back to Search
Nonsteroidal Anti-inflammatory Drug
Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
Phase 4
Waitlist Available
Led By Carlos Buznego, MD
Research Sponsored by Center For Excellence In Eye Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.
Eligible Conditions
- Macular Edema
- Retinal Thickening
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment1 Intervention
Group II: 1Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bromfenac
FDA approved
Find a Location
Who is running the clinical trial?
Center For Excellence In Eye CareLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Carlos Buznego, MDPrincipal InvestigatorThe Center for Excellence in Eye Care