Effectiveness of Periocular Drug Injection in CATaract Surgery

NCT05158699 | Terminated Phase 3 DMC

• 2 other identifiers: NL72427.068.192019-004890-21
• Study Type: interventional
• Target: 628
• Locations: 4 countries
• Sites: 10

Brief Summary

Cystoid macular edema (CME) is a major cause of suboptimal postoperative visual acuity after cataract surgery. Topical steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) are used to prevent CME. However, noncompliance with eye drops may compromise the effectiveness of treatment. Dropless periocular drug delivery during cataract surgery may improve the outcomes and cost-effectiveness of cataract surgery, and may alleviate the burden on homecare organizations.

Conditions

Macular Edema; Cystoid Macular Edema; Retinal Disease; Cataract; Lens Diseases; Eye Diseases

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, measured using Optical Coherence Tomography (OCT)

  Baseline, 6 weeks postoperatively

Secondary Outcomes (20)

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

  Baseline, 12 weeks postoperatively

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

  Until 12 weeks postoperatively

• Change in parafoveal retinal thickness in the central inner circle (1.0 - 3.0mm) as a measurement of efficacy

  Baseline, 6 weeks and 12 weeks postoperatively

• Change in perifoveal retinal thickness in the central outer circle (3.0 - 6.0mm) as a measurement of efficacy

  Baseline, 6 weeks and 12 weeks postoperatively

• Change in macular volume in the central 6.0mm area as a measurement of efficacy

  Baseline, 6 weeks and 12 weeks postoperatively

Study Arms (4)

topical bromfenac & dexamethasone

ACTIVE COMPARATOR

bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperatively \& 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: Bromfenac; Drug: Dexamethasone

subconjunctival triamcinolone acetonide

ACTIVE COMPARATOR

one subconjunctival injection of 10 mg triamcinolone acetonide during cataract surgery (TA, Triesence/Vistrec) in the inferotemporal quadrant, 6mm from the limbus.

Drug: Triamcinolone Acetonide

intracameral ketorolac

ACTIVE COMPARATOR

intracameral injection of ketorolac tromethamine solution during cataract surgery (Omidria). A 4ml vial of Omidria (ketorolac concentration 2.88mg/ml) is added to 500ml of the irrigation solution used during cataract surgery, resulting in a ketorolac concentration of 0.023mg/ml. At the end of the surgery, the anterior chamber will be filled with the ketorolac solution.

Drug: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution

subconjunctival triamcinolone acetonide & intracameral ketorolac

ACTIVE COMPARATOR

one subconjunctival injection of 10 mg triamcinolone acetonide \& intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery.

Drug: Triamcinolone Acetonide; Drug: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution

Interventions

Bromfenac DRUG

Bromfenac topical eye drops (Yellox)

Also known as: Yellox, Product code: EU/1/11/692

topical bromfenac & dexamethasone

Dexamethasone DRUG

Dexamethasone topical eye drops

Also known as: Dexamethasone ophthalmic solution, Product code (NL): RVG 56003

topical bromfenac & dexamethasone

Triamcinolone Acetonide DRUG

0.25ml of 40mg/ml (10mg) triamcinolone acetonide (Triesence/Vistrec) will be injected subconjunctivally

Also known as: Triesence or Vistrec, Product code (NL): RVG 106092

subconjunctival triamcinolone acetonide; subconjunctival triamcinolone acetonide & intracameral ketorolac

Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution DRUG

Omidria is added to the irrigation fluid used during cataract surgery. At the end of surgery, the anterior chamber will be filled with the ketorolac solution.

Also known as: Omidria

intracameral ketorolac; subconjunctival triamcinolone acetonide & intracameral ketorolac

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who are undergoing routine phacoemulsification (one eye per patient);
• who are 21 years or older;
• who should be able to communicate properly and understand instructions.
• willing and/or able to comply with the scheduled visits and other study procedures.

You may not qualify if:

• patients who already participated with their contralateral eye;
• combined surgery (e.g. combined phacoemulsification and trabeculectomy);
• patients with an increased risk of developing cystoid macular edema (CME) in the study eye (e.g. diabetes mellitus, previous retinal venous occlusion, or a history of uveitis, macular edema, epiretinal membrane, or previous retinal surgery);
• patients who developed CME after cataract surgery in the contralateral eye;
• patients with cystoid macular changes in the study eye at baseline;
• patients with an increased risk of developing perioperative complications (e.g. Fuchs' endothelial dystrophy);
• patients with permanent moderate visual impairment in the contralateral eye (decimal visual acuity less than 0.3);
• patients with a history of steroid induced IOP rise or glaucomatous visual field loss;
• patients using drugs that reduce or increase the risk of macular edema (e.g., periocular or intraocular corticosteroid, NSAID, or antivascular endothelial growth factor (VEGF) injection; topical corticosteroid or NSAID use; systemic corticosteroids (\>= 20mg prednisolon), methotrexate, biologicals, or acetazolamide), or in the previous 4 months;
• patients with a contraindication for any of the investigated drugs;
• patients who are cardiovascular unstable;
• patients who have a history of hyperthyroidism.

Sponsors & Collaborators

• Luigi Rondas: lead
• European Society of Cataract and Refractive Surgeons: collaborator

Study Sites (10)

Hospital of the Brothers of Saint John of God

Vienna, 1020, Austria

Location

Vienna Institute for Research in Ocular Surgery, Hanusch Krankenhaus

Vienna, A-1140, Austria

Location

Goethe University

Frankfurt am Main, 60590, Germany

Location

Amphia

Breda, 4818 CK, Netherlands

Location

Deventer Ziekenhuis

Deventer, 7416SE, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, 6419 PC, Netherlands

Location

University Eye Clinic Maastricht UMC+

Maastricht, 6229HX, Netherlands

Location

Canisius Wilhelmina Ziekenhuis Nijmegen

Nijmegen, 6532SZ, Netherlands

Location

Elisabeth-Twee Steden Ziekenhuis, locatie Elisabeth

Tilburg, 5022GC, Netherlands

Location

University Hospital Coimbra

Coimbra, 3000-075, Portugal

Location

MeSH Terms

Conditions

Macular Edema; Retinal Diseases; Cataract; Lens Diseases; Eye Diseases

Interventions

bromfenac; Dexamethasone; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nienke Visser, Dr.

  Universiteitskliniek voor Oogheelkunde Maastricht UMC+

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masking will be achieved as much as possible. As there is an objective primary outcome, it will not be necessary to replace medicines by sham injections or placebo eye drops. Moreover, the ophthalmologist who performs the cataract surgery will not be blinded for treatment allocation of the subject. The study statistician, the data safety monitoring group, optometrists who perform the examinations (especially visual acuity) and observers who evaluate the examinations and OCTs will be masked when possible for treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator ESCRS EPICAT study

Model Details: A block randomization procedure will be followed to acquire equal number of subjects in every treatment group. Patients are randomly allocated to 1 of 4 treatment groups in a 1:1:1:1 ratio. The various study centres will be taken into account during randomization.

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 15, 2021
• Study Start: October 13, 2021
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); NL (6); DE (1); PT (1)