NCT01774474

Brief Summary

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,127

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2013

Typical duration for phase_3

Geographic Reach
7 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

July 10, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2016

Completed
Last Updated

April 14, 2017

Status Verified

May 1, 2016

Enrollment Period

3.3 years

First QC Date

January 7, 2013

Last Update Submit

April 13, 2017

Conditions

Cystoid Macular EdemaCataractDiabetes Mellitus

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

  • Change in central subfield mean macular thickness as a measurement of efficacy

    The primary endpoint is the change in central subfield mean macular thickness in the 1 mm area (central subfield macular thickness, CSMT) as compared to baseline within the first 6 weeks postoperatively.

    6 weeks postoperatively

Secondary Outcomes (1)

  • No. of subjects developing clinically significant macular edema as a measurement of efficacy

    12 weeks postoperatively

Other Outcomes (16)

  • Change in corrected distance visual acuity (CDVA) as a measurement of efficacy

    6 postoperatively

  • Change in retinal thickness in the central inner circle (3mm) as a measurement of efficacy

    6 weeks postoperatively

  • Intraocular pressure (IOP) as a measurement of safety

    6 postoperatively

  • +13 more other outcomes

Study Arms (7)

Non diabetics: bromfenac

ACTIVE COMPARATOR

bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperatively

Drug: Bromfenac

Non diabetics: dexamethasone

ACTIVE COMPARATOR

dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week

Drug: Dexamethasone

Non diabetics: bromfenac & dexamethasone

ACTIVE COMPARATOR

bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week

Drug: BromfenacDrug: Dexamethasone

Diabetics: eye drops

ACTIVE COMPARATOR

bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week

Drug: BromfenacDrug: Dexamethasone

Diabetics: eye drops & TA

ACTIVE COMPARATOR

bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA, Triesence/Vistrec)

Drug: BromfenacDrug: DexamethasoneDrug: Triamcinolone Acetonide

Diabetics: eye drops & bevacizumab

ACTIVE COMPARATOR

bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week \& a peroperative intravitreal injection of 1.25 mg bevacizumab (Avastin)

Drug: BromfenacDrug: DexamethasoneDrug: Bevacizumab

Diabetics: eye drops, TA & bevacizumab

ACTIVE COMPARATOR

bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative, dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA) \& a peroperative intravitreal injection of 1.25 mg bevacizumab

Drug: BromfenacDrug: DexamethasoneDrug: BevacizumabDrug: Triamcinolone Acetonide

Interventions

BromfenacDRUG
Also known as: Yellox, Product code: EMEA/H/C/001198
Diabetics: eye dropsDiabetics: eye drops & TADiabetics: eye drops & bevacizumabDiabetics: eye drops, TA & bevacizumabNon diabetics: bromfenacNon diabetics: bromfenac & dexamethasone
DexamethasoneDRUG
Also known as: Dexamethasone ophthalmic solution, Product code (NL): RVG 56003
Diabetics: eye dropsDiabetics: eye drops & TADiabetics: eye drops & bevacizumabDiabetics: eye drops, TA & bevacizumabNon diabetics: bromfenac & dexamethasoneNon diabetics: dexamethasone
BevacizumabDRUG
Also known as: Avastin, Product code: EU/1/04/300/002
Diabetics: eye drops & bevacizumabDiabetics: eye drops, TA & bevacizumab
Triamcinolone AcetonideDRUG
Also known as: Triesence or Vistrec, Product code (NL): RVG 106092
Diabetics: eye drops & TADiabetics: eye drops, TA & bevacizumab

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing routine phacoemulsification (one eye per patient)
  • willing and/or able to comply with the scheduled visits and other study procedures.
  • able to communicate properly and understand instructions.
  • accepting possible off-label use of intravitreal bevacizumab and/or subconjunctival preservative-free TA.

You may not qualify if:

  • age below 21 years old;
  • participation in another clinical study;
  • post-traumatic cataract;
  • combined surgery;
  • functional monoculus;
  • previous ocular surgery;
  • progressive glaucoma with severe visual field defects, use of anti-glaucomatous medication or steroid-induced IOP elevation that required IOP-lowering treatment;
  • IOP ≥ 25 mmHg;
  • history of any intraocular inflammation or uveitis;
  • history of pseudoexfoliation syndrome, which is expected to cause peroperative complications;
  • history of Fuchs' endothelial dystrophy or cornea guttata 3+;
  • history of retinal vein occlusion;
  • any macular pathology that might influence VA, other than DME;
  • use of intravitreal bevacizumab or ranibizumab in the previous 6 weeks or intravitreal aflibercept in the previous 10 weeks;
  • use of intra- or periocular corticosteroid injection in the previous 4 months;
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Vienna Institute for Research in Ocular Surgery, Hanusch Krankenhaus

Vienna, A-1140, Austria

Location

Hospital of the Brothers of Saint John of God

Vienna, Austria

Location

University Hospital Antwerp

Edegem, B-2650, Belgium

Location

Goethe University

Frankfurt am Main, 60590, Germany

Location

Semmelweis University

Budapest, H-1085, Hungary

Location

VU University Medical Center

Amsterdam, 1081 HZ, Netherlands

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Amphia Hospital Breda

Breda, Netherlands

Location

Zuyderland Medical Center

Heerlen, 6419 PC, Netherlands

Location

Eye Hospital Zonnestraal

Hilversum, Netherlands

Location

University Eye Clinic Maastricht UMC+

Maastricht, 6202 AZ, Netherlands

Location

Medical Centre Haaglanden

The Hague, Netherlands

Location

St. Elisabeth Hospital

Tilburg, Netherlands

Location

Máxima Medical Center Veldhoven

Veldhoven, Netherlands

Location

University Hospital Coimbra

Coimbra, 3000-075, Portugal

Location

Instituto Microcirurgia Ocular

Barcelona, 08035, Spain

Location

Related Publications (2)

  • Simons RWP, Wielders LHP, Nuijts RMMA, Veldhuizen CA, van den Biggelaar FJHM, Winkens B, Schouten JSAG, Dirksen CD; ESCRS PREMED Study Group. Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6. J Cataract Refract Surg. 2022 May 1;48(5):555-563. doi: 10.1097/j.jcrs.0000000000000785.

    PMID: 34417781DERIVED

  • Simons RWP, Wielders LHP, Dirksen CD, Veldhuizen CA, van den Biggelaar FJHM, Winkens B, Schouten JSAG, Nuijts RMMA; ESCRS PREMED Study Group. Economic evaluation of prevention of cystoid macular edema after cataract surgery in patients without diabetes: ESCRS PREMED study report 4. J Cataract Refract Surg. 2021 Mar 1;47(3):331-339. doi: 10.1097/j.jcrs.0000000000000449.

    PMID: 33009281DERIVED

MeSH Terms

Conditions

Macular EdemaCataractDiabetes Mellitus

Interventions

bromfenacDexamethasoneBevacizumabTriamcinolone AcetonideTriamcinolone

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesLens DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • prof. Rudy MM Nuijts, MD, PhD

    University Eye Clinic Maastricht, University Hospital Maastricht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 24, 2013

Study Start

July 10, 2013

Primary Completion

November 4, 2016

Study Completion

November 4, 2016

Last Updated

April 14, 2017

Record last verified: 2016-05

Locations

ES(1)NL(9)AU(2)HU(1)PT(1)DE(1)BE(1)