Macular EdemaPhase 3EPICATNCT05158699
Effectiveness of Periocular Drug Injection in CATaract Surgery
A Phase 3 study testing Bromfenac, Dexamethasone and Triamcinolone Acetonide in people with Macular Edema and Cystoid Macular Edema, run by Luigi Rondas at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Macular Edema, Cystoid Macular Edema, Retinal Disease
- What is being tested?
- Bromfenac, Dexamethasone and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 13 Oct 2021to 13 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 12Show fewer
- 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.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Netherlands6 sites
Amphia
Breda, 4818 CK
Deventer Ziekenhuis
Deventer, 7416SE
Zuyderland Medisch Centrum
Heerlen, 6419 PC
University Eye Clinic Maastricht UMC+
Maastricht, 6229HX
Canisius Wilhelmina Ziekenhuis Nijmegen
Nijmegen, 6532SZ
Elisabeth-Twee Steden Ziekenhuis, locatie Elisabeth
Tilburg, 5022GC
Austria2 sites
Hospital of the Brothers of Saint John of God
Vienna, 1020
Vienna Institute for Research in Ocular Surgery, Hanusch Krankenhaus
Vienna, A-1140
About this study
Official title: The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery
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.
Read the detailed description
In a recent European multicentre study (PREvention of Macular EDema after cataract surgery; PREMED), it was demonstrated that the combination of topical corticosteroids and NSAIDs results in the lowest risk of developing CME after cataract surgery. However, noncompliance with eye drops may compromise the effectiveness of treatment. Noncompliance is often unintentional and related to forgetfulness or incorrect instillation, particularly in the elderly cataract surgery population.
The objective of this study is to evaluate the effectiveness of different treatments to prevent CME after cataract surgery, using either topical drugs (control group) or intra-/periocular injections (intervention groups).
The hypothesis of this study is that intra-/periocular anti-inflammatory drug delivery during cataract surgery is effective in preventing CME, with better health-related quality of life and improved cost-effectiveness compared to standard topical drug delivery.
The primary outcome measure is the change in central subfield mean macular thickness (CSMT) at 6 weeks postoperatively as compared to baseline. Secondary outcome measures are the incidence of CME; the incidence of clinically significant macular edema (CSME); mean corrected distance visual acuity (CDVA); para- and perifoveal thickness and total macular volume (TMV); intraocular pressure (IOP); anterior chamber inflammation; vision-related quality of life; and cost-effectiveness.
The design of this study is a European randomised controlled multicenter trial. The study population will consist of 808 patients aged 21 years or older who require cataract surgery in at least one eye. Patients with a foreseen increased risk of developing CME or ophthalmic disorders other than cataract will be excluded. Follow-up duration is 12 weeks. The study will be conducted over a period of 36 months.
- Conditions
- Macular Edema, Cystoid Macular Edema, Retinal Disease, Cataract, Lens Diseases, Eye Diseases
- Being tested
- Bromfenac, Dexamethasone, Triamcinolone Acetonide, Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution
- Keywords
- Prevention
- Medical subject headings
- Macular Edema, Retinal Diseases, Cataract, Lens Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromfenacDrug
Also called Yellox, Product code: EU/1/11/692
Bromfenac topical eye drops (Yellox)
DexamethasoneDrug
Also called Dexamethasone ophthalmic solution, Product code (NL): RVG 56003
Dexamethasone topical eye drops
Triamcinolone AcetonideDrug
Also called Triesence or Vistrec, Product code (NL): RVG 106092
0.25ml of 40mg/ml (10mg) triamcinolone acetonide (Triesence/Vistrec) will be injected subconjunctivally
Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular SolutionDrug
Also called Omidria
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Triamcinolone Acetonide; Drug: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 6 weeks postoperatively
Secondary outcomes (20)
Change in central subfield mean macular thickness as a measurement of efficacy
Measured using OCT
Measured: Baseline, 12 weeks postoperatively
No. of subjects developing clinically significant macular edema as a measurement of efficacy
The occurrence of postoperative clinically significant macular edema (CSME) within 12 weeks postoperatively
Measured: Until 12 weeks postoperatively
Change in parafoveal retinal thickness in the central inner circle (1.0 - 3.0mm) as a measurement of efficacy
Measured using OCT
Measured: 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
Measured using OCT
Measured: Baseline, 6 weeks and 12 weeks postoperatively
Change in macular volume in the central 6.0mm area as a measurement of efficacy
Measured using OCT
Measured: Baseline, 6 weeks and 12 weeks postoperatively
Change in corrected distance visual acuity (CDVA) as a measurement of efficacy
CDVA measurements will be taken using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts (logMAR)
Measured: Baseline, 1 week, 6 weeks, and 12 weeks postoperatively
Change in Intraocular pressure (IOP) as a measurement of safety
IOP (in mmHg) will be measured by Goldmann applanation tonometry (preferred), Non-Contact Tonometry, or iCare tonometry
Measured: Baseline, 1 week, 6 weeks, and 12 weeks postoperatively
Anterior chamber inflammation as a measurement of safety
Grading will be performed using the classification of the "Standardization of Uveitis Nomenclature" (SUN) working group using a 2mm long and 1mm wide slit beam:
- grading aqueous cells between grade 0 [<1cell, best outcome] up to grade +4 [>50 cells, worse outcome]
- grading aqueous flare between grade 0 [none detectable] up to +4 [intense aqeous flare or fibrinous exudate] Higher grade scores mean a worse outcome.
Measured: Baseline, 1 week , 6 weeks, and 12 weeks postoperatively
No. of subjects with Adverse Events as a measurement of safety and tolerability
An adverse event (AE) is defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product. All adverse events reported spontaneously by the subject or observed by the principal investigator or his staff will be recorded.
Most frequently reported adverse events which might occur while using the study medication: abnormal sensation in the eye, pain or irritation, redness or headache while using eye drops; increased IOP and masking of infections while using corticosteroids; abnormal sensation in the eye, pain or irritation, conjunctival hyperaemia, inflammation and corneal edema after intracameral injection with phenylephrine/ketorolac.
Measured: Until 12 weeks postoperatively
Patient reported outcome measures (PROMs): NEI VFQ-25
Patient satisfaction and vision-specific quality of life as measured by National Eye Institute Visual Function Questionnaire (NEI VFQ-25). From 25 questions, the original numeric values given (1-10) are converted to a 0 to 100 scale, so that the scores are set between 0 points (worst outcome) and 100 points (best outcome).
Measured: Baseline and 12 weeks postoperatively
Patient reported outcome measures (PROMs): Catquest-9SF
Patient satisfaction and vision-specific quality of life as measured by the Catquest-9SF questionnaire. The possible range in Catquest scores are -3.94 (no difficulties) to +3.52 (great difficulties).
Measured: Baseline and 12 weeks postoperatively
Patient reported outcome measures (PROMs): HUI3
Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire. The HUI3 questionnaire consists of 8 attributes, including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. For each attribute, the HUI3 questionnaire provides utility (preference) scores on a generic scale where dead = 0.00 and perfect health = 1.00.
Measured: Baseline and 12 weeks postoperatively
Patient reported outcome measures (PROMs): EQ-5D-5L
Health-related quality of life as measured by the 5-level EQ-5D version (EQ-5D-5L) questionnaire. The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
- The EQ-5D descriptive system results in a number between 1 (best) and 5 (worse) that expresses the level selected for that dimension.
- The EQ VAS indicates the general health status with 0 indicating the worst and 100 indicating the best health status.
Measured: Baseline and 12 weeks postoperatively
Quality Adjusted Life Years (QALYs)
Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires
Measured: Baseline until 12 weeks postoperatively
Costs per patient
Cost per patient, including valuation of resource use by using the Dutch guidelines for cost-analyses or cost prices provided by the medical center.
Measured: Baseline until 12 weeks postoperatively
Incremental cost-effectiveness ratios (ICERs): QALY
Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)
Measured: Baseline until 12 weeks postoperatively
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire
Measured: Baseline until 12 weeks postoperatively
Incremental cost-effectiveness ratios (ICERs): Catquest
Calculated costs per clinically improved patient on the Catquest questionnaire
Measured: Baseline until 12 weeks postoperatively
Incremental cost-effectiveness ratios (ICERs): Visual acuity
Calculated costs per patient with clinical improvement in (un)corrected distance visual acuity
Measured: Baseline until 12 weeks postoperatively
Budget impact
Reported as a difference in costs. Different scenario's will be compared to investigate the impact of various levels of implementation (e.g. 25%, 50%, 75% of eligible patients).
Measured: Baseline until 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start13 Oct 2021
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Why it stopped: Results of interim analysis: stop the trial due to one group being significantly different from the other three groups. Furthermore, shortage of study medication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luigi Rondas
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Cataract and Refractive Surgeons
- Responsible party
- Sponsor-investigator, Luigi Rondas, Academisch Ziekenhuis Maastricht
- Investigators
- Nienke Visser, Dr., Principal investigator, Universiteitskliniek voor Oogheelkunde Maastricht UMC+
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158699
- Sponsor's protocol ID
- NL72427.068.19
- Other IDs
- 2019-004890-21, 2019
- Acronym
- EPICAT
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery
- ClinicalTrials.gov ID
- NCT05158699
- Acronym / sponsor ID
- EPICAT / NL72427.068.19
- Conditions
- Macular Edema, Cystoid Macular Edema, Retinal Disease, Cataract, Lens Diseases, Eye Diseases
- Keywords
- Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of interim analysis: stop the trial due to one group being significantly different from the other three groups. Furthermore, shortage of study medication.
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Luigi RondasUniversity, hospital or other
- Collaborators
- European Society of Cataract and Refractive Surgeons
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In a recent European multicentre study (PREvention of Macular EDema after cataract surgery; PREMED), it was demonstrated that the combination of topical corticosteroids and NSAIDs results in the lowest risk of developing CME after cataract surgery. However, noncompliance with eye drops may compromise the effectiveness of treatment. Noncompliance is often unintentional and related to forgetfulness or incorrect instillation, particularly in the elderly cataract surgery population.
The objective of this study is to evaluate the effectiveness of different treatments to prevent CME after cataract surgery, using either topical drugs (control group) or intra-/periocular injections (intervention groups).
The hypothesis of this study is that intra-/periocular anti-inflammatory drug delivery during cataract surgery is effective in preventing CME, with better health-related quality of life and improved cost-effectiveness compared to standard topical drug delivery.
The primary outcome measure is the change in central subfield mean macular thickness (CSMT) at 6 weeks postoperatively as compared to baseline. Secondary outcome measures are the incidence of CME; the incidence of clinically significant macular edema (CSME); mean corrected distance visual acuity (CDVA); para- and perifoveal thickness and total macular volume (TMV); intraocular pressure (IOP); anterior chamber inflammation; vision-related quality of life; and cost-effectiveness.
The design of this study is a European randomised controlled multicenter trial. The study population will consist of 808 patients aged 21 years or older who require cataract surgery in at least one eye. Patients with a foreseen increased risk of developing CME or ophthalmic disorders other than cataract will be excluded. Follow-up duration is 12 weeks. The study will be conducted over a period of 36 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| topical bromfenac & dexamethasone | Active comparator | Drug: Bromfenac, Drug: Dexamethasonebromfenac 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. |
| subconjunctival triamcinolone acetonide | Active comparator | Drug: Triamcinolone Acetonideone subconjunctival injection of 10 mg triamcinolone acetonide during cataract surgery (TA, Triesence/Vistrec) in the inferotemporal quadrant, 6mm from the limbus. |
| intracameral ketorolac | Active comparator | Drug: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solutionintracameral 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. |
| subconjunctival triamcinolone acetonide & intracameral ketorolac | Active comparator | Drug: Triamcinolone Acetonide, Drug: Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solutionone subconjunctival injection of 10 mg triamcinolone acetonide \& intracameral injection of ketorolac tromethamine solution (Omidria; 0.023mg/mL) during cataract surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BromfenacAlso: Yellox, Product code: EU/1/11/692Bromfenac topical eye drops (Yellox) | Drug | topical bromfenac & dexamethasone |
| DexamethasoneAlso: Dexamethasone ophthalmic solution, Product code (NL): RVG 56003Dexamethasone topical eye drops | Drug | topical bromfenac & dexamethasone |
| Triamcinolone AcetonideAlso: Triesence or Vistrec, Product code (NL): RVG 1060920.25ml of 40mg/ml (10mg) triamcinolone acetonide (Triesence/Vistrec) will be injected subconjunctivally | Drug | subconjunctival triamcinolone acetonide, subconjunctival triamcinolone acetonide & intracameral ketorolac |
| Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular SolutionAlso: OmidriaOmidria 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. | Drug | intracameral ketorolac, subconjunctival triamcinolone acetonide & intracameral ketorolac |
Primary outcome
Change in central subfield mean macular thickness as a measurement of efficacy
Time frame: Baseline, 6 weeks postoperatively
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)
20 secondary outcomes
Change in central subfield mean macular thickness as a measurement of efficacy
Time frame: Baseline, 12 weeks postoperatively
No. of subjects developing clinically significant macular edema as a measurement of efficacy
Time frame: Until 12 weeks postoperatively
Change in parafoveal retinal thickness in the central inner circle (1.0 - 3.0mm) as a measurement of efficacy
Time frame: 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
Time frame: Baseline, 6 weeks and 12 weeks postoperatively
Change in macular volume in the central 6.0mm area as a measurement of efficacy
Time frame: Baseline, 6 weeks and 12 weeks postoperatively
Change in corrected distance visual acuity (CDVA) as a measurement of efficacy
Time frame: Baseline, 1 week, 6 weeks, and 12 weeks postoperatively
Change in Intraocular pressure (IOP) as a measurement of safety
Time frame: Baseline, 1 week, 6 weeks, and 12 weeks postoperatively
Anterior chamber inflammation as a measurement of safety
Time frame: Baseline, 1 week , 6 weeks, and 12 weeks postoperatively
No. of subjects with Adverse Events as a measurement of safety and tolerability
Time frame: Until 12 weeks postoperatively
Patient reported outcome measures (PROMs): NEI VFQ-25
Time frame: Baseline and 12 weeks postoperatively
Patient reported outcome measures (PROMs): Catquest-9SF
Time frame: Baseline and 12 weeks postoperatively
Patient reported outcome measures (PROMs): HUI3
Time frame: Baseline and 12 weeks postoperatively
Patient reported outcome measures (PROMs): EQ-5D-5L
Time frame: Baseline and 12 weeks postoperatively
Quality Adjusted Life Years (QALYs)
Time frame: Baseline until 12 weeks postoperatively
Costs per patient
Time frame: Baseline until 12 weeks postoperatively
Incremental cost-effectiveness ratios (ICERs): QALY
Time frame: Baseline until 12 weeks postoperatively
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
Time frame: Baseline until 12 weeks postoperatively
Incremental cost-effectiveness ratios (ICERs): Catquest
Time frame: Baseline until 12 weeks postoperatively
Incremental cost-effectiveness ratios (ICERs): Visual acuity
Time frame: Baseline until 12 weeks postoperatively
Budget impact
Time frame: Baseline until 12 weeks postoperatively
Results and safety
The study was stopped early (reason given: Results of interim analysis: stop the trial due to one group being significantly different from the other three groups. Furthermore, shortage of study medication.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nienke Visser, Dr. principal investigator
Universiteitskliniek voor Oogheelkunde Maastricht UMC+
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bromfenac, Dexamethasone and Triamcinolone Acetonide in people with Macular Edema and Cystoid Macular Edema, run by Luigi Rondas at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, Austria, Germany, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Results of interim analysis: stop the trial due to one group being significantly different from the other three groups. Furthermore, shortage of study medication.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in central subfield mean macular thickness as a measurement of efficacy (time frame: Baseline, 6 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.