NCT01774474 (PREMED) is a Phase 3 clinical trial of Bromfenac in Cystoid Macular Edema, sponsored by Maastricht University Medical Center.

Who is sponsoring NCT01774474?

NCT01774474 is sponsored by Maastricht University Medical Center.

What drugs are being tested in NCT01774474?

Interventions in NCT01774474: Bromfenac, Dexamethasone, Bevacizumab, Triamcinolone Acetonide.

What condition does NCT01774474 study?

NCT01774474 studies Cystoid Macular Edema, Cataract, Diabetes Mellitus.

Is NCT01774474 still recruiting?

NCT01774474 is currently completed. Last updated 14 April 2017.

Last reviewed 2017-04-14 · How we verify

NCT01774474: PREMED

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PRevention of Macular EDema After Cataract Surgery

Completed Phase 3 Last updated 14 April 2017

What this trial tests

Phase 3 trial testing Bromfenac in Cystoid Macular Edema in 1,127 participants. Completed in 4 November 2016.

Timeline

10 July 2013

Primary endpoint
4 November 2016

4 November 2016

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,127
Start date	10 July 2013
Primary completion	4 November 2016
Estimated completion	4 November 2016
Sites	16 locations across Netherlands, Belgium, Austria, Germany, Hungary, Portugal, Spain

Drugs / interventions tested

Bromfenac (BROMFENAC) — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Triamcinolone Acetonide

Conditions studied

Cystoid Macular Edema — all drugs for Cystoid Macular Edema →
Cataract — all drugs for Cataract →
Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Maastricht University Medical Center

Who can join

21 and older, any sex, with Cystoid Macular Edema or Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. The investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Non-steroidal anti-inflammatory drugs versus corticosteroids for controlling inflammation after uncomplicated cataract surgery.
Juthani VV, Clearfield E, Chuck RS. · · 2017 · cited 58× · PMID 28670710 · DOI 10.1002/14651858.cd010516.pub2
Prophylactic non-steroidal anti-inflammatory drugs for the prevention of macular oedema after cataract surgery.
Lim BX, Lim CH, Lim DK, Evans JR, et al · · 2016 · cited 31× · PMID 27801522 · DOI 10.1002/14651858.cd006683.pub3

Verify or expand the search:

Other trials of Bromfenac

Trials testing the same drug.

NCT06785090 — Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery · Phase 4 · completed
NCT05158699 — Effectiveness of Periocular Drug Injection in CATaract Surgery · Phase 3 · terminated
NCT04343222 — Control of Pain in Intravitreal Injections Using Topical NSAIDs · Phase 4 · completed

Other recruiting trials for Cystoid Macular Edema

Currently open trials in the same condition.

NCT07002372 — Effect of Video Viewing on Intravitreal Injection Experience · NA · recruiting
NCT04225611 — Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema · Phase 1, PHASE2 · recruiting

Other Maastricht University Medical Center trials

Trials by the same sponsor.

NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01774474 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
Last refreshed: 14 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01774474.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing