Cystoid Macular EdemaPhase 3PREMEDNCT01774474
PRevention of Macular EDema After Cataract Surgery
A Phase 3 study testing Bromfenac, Dexamethasone and Bevacizumab in people with Cystoid Macular Edema and Cataract, run by Maastricht University Medical Center at 16 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cystoid Macular Edema, Cataract, Diabetes Mellitus
- What is being tested?
- Bromfenac, Dexamethasone and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,127 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 10 Jul 2013to 4 Nov 2016
- 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
- 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.
- Exclusion criteria will be different for non-diabetic and diabetic patients. All ophthalmic exclusion criteria are applicable to the study eye only, unless stated otherwise.
- General exclusion criteria for participation in this study are:
Show all 35Show fewer
- 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;
- current use of topical NSAIDs or corticosteroids;
- use of systemic corticosteroids (≥ 20 mg prednisolone or equivalence);
- history of relevant adverse events, including serious adverse events (SAE), occurring after administration of NSAIDs, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab;
- contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab or related drugs;
- Non-diabetic patients with a history of CME will be excluded from participation in the study.
- Additionally, diabetic patients will be excluded from participation in case of:
- macular edema with a CSMT ≥450 µm;
- very severe NPDR or proliferative DR requiring panretinal photocoagulation or vitrectomy;
- vitreous haemorrhage present during preoperative visit(s);
- cerebrovascular accident (CVA), myocardial infarction (MI) or other thromboembolic events in the previous 3 months;
- a history of recurrent thromboembolic events;
- a history of severe systemic bleeding in the previous 3 months;
- major surgery in the previous 3 months;
- history of glaucoma;
Who cannot join
None listed.
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Netherlands9 sites
VU University Medical Center
Amsterdam, 1081 HZ
Academic Medical Center
Amsterdam
Amphia Hospital Breda
Breda
Zuyderland Medical Center
Heerlen, 6419 PC
Eye Hospital Zonnestraal
Hilversum
University Eye Clinic Maastricht UMC+
Maastricht, 6202 AZ
Medical Centre Haaglanden
The Hague
St. Elisabeth Hospital
Tilburg
Máxima Medical Center Veldhoven
Veldhoven
Austria2 sites
Vienna Institute for Research in Ocular Surgery, Hanusch Krankenhaus
Vienna, A-1140
Hospital of the Brothers of Saint John of God
Vienna
About this study
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).
Read the detailed description
The objective of this study is to evaluate the effect of different preventive strategies on the occurrence of CME after cataract surgery in non-diabetic and diabetic patients. The design of the study is a multicentre randomised controlled clinical trial. The study population will consist of 926 non-diabetic patients and 209 patients with diabetes mellitus (DM) who require cataract surgery in at least one eye. All patients will receive a phacoemulsification for cataract and placement of a posterior chamber intraocular lens (IOL).
In the non-diabetic population, the patients will receive either 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 or a combination of both drugs.
In the diabetic population patients will receive either:
- Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose;
- Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose and a subconjunctival injection of 40 mg triamcinolone acetonide;
- Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose and an intravitreal injection of 1.25 mg bevacizumab;
- Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose, a subconjunctival injection of 40 mg triamcinolone acetonide and an intravitreal injection of 1.25 mg bevacizumab.
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 postoperative.
The secondary endpoint is the occurrence of postoperative clinically significant macular edema (CSME) within 12 weeks postoperatively. Other study endpoints are mean CDVA in logMAR at 6 weeks and 12 weeks postoperatively; OCT measured average retinal thickness in the central inner circle (3mm), the outer circle (6mm), and the macular volume at 6 weeks and 12 weeks postoperatively; intraocular pressure at 6 weeks and 12 weeks postoperatively.
In case of clinically significant macular edema, treatment will be initiated and its effect will be part of the evaluation at 12 weeks. Medical data of all patients who develop macular edema during this study will be checked at least 6 months after surgery.
- Conditions
- Cystoid Macular Edema, Cataract, Diabetes Mellitus
- Being tested
- Bromfenac, Dexamethasone, Bevacizumab, Triamcinolone Acetonide
- Keywords
- Prevention
- Medical subject headings
- Macular Edema, Cataract, Diabetes Mellitus
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: EMEA/H/C/001198
DexamethasoneDrug
Also called Dexamethasone ophthalmic solution, Product code (NL): RVG 56003
BevacizumabDrug
Also called Avastin, Product code: EU/1/04/300/002
Triamcinolone AcetonideDrug
Also called Triesence or Vistrec, Product code (NL): RVG 106092
| Study group | Role | What they receive |
|---|---|---|
| Non diabetics: bromfenac | Active comparator | bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperatively Receives: 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 Receives: 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 Receives: Drug: Bromfenac; Drug: 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 Receives: Drug: Bromfenac; Drug: 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) Receives: Drug: Bromfenac; Drug: Dexamethasone; Drug: 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) Receives: Drug: Bromfenac; Drug: Dexamethasone; Drug: 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 Receives: Drug: Bromfenac; Drug: Dexamethasone; Drug: Bevacizumab; Drug: Triamcinolone Acetonide |
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: 6 weeks postoperatively
Secondary outcomes (1)
No. of subjects developing clinically significant macular edema as a measurement of efficacy
The secondary endpoint is the occurrence of postoperative clinically significant macular edema (CSME) within 12 weeks postoperatively.
Measured: 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 posted24 Jan 2013 (estimated)
- Study start10 Jul 2013
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystoid Macular EdemaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Cataract and Refractive Surgeons
- Responsible party
- Sponsor
- Investigators
- prof. Rudy MM Nuijts, MD, PhD, Principal investigator, University Eye Clinic Maastricht, University Hospital Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774474
- Sponsor's protocol ID
- NL42463.068.12
- Acronym
- PREMED
- Status last verified
- May 2016
- First submitted
- 7 Jan 2013
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34417781Simons 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.
PubMed 33009281
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRevention of Macular EDema After Cataract Surgery
- ClinicalTrials.gov ID
- NCT01774474
- Acronym / sponsor ID
- PREMED / NL42463.068.12
- Conditions
- Cystoid Macular Edema, Cataract, Diabetes Mellitus
- Keywords
- Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,127 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- European Society of Cataract and Refractive Surgeons
- Study start
- 10 Jul 2013 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 24 Jan 2013 (estimated)
- 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 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).
Detailed description
The objective of this study is to evaluate the effect of different preventive strategies on the occurrence of CME after cataract surgery in non-diabetic and diabetic patients. The design of the study is a multicentre randomised controlled clinical trial. The study population will consist of 926 non-diabetic patients and 209 patients with diabetes mellitus (DM) who require cataract surgery in at least one eye. All patients will receive a phacoemulsification for cataract and placement of a posterior chamber intraocular lens (IOL).
In the non-diabetic population, the patients will receive either 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 or a combination of both drugs.
In the diabetic population patients will receive either:
- Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose;
- Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose and a subconjunctival injection of 40 mg triamcinolone acetonide;
- Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose and an intravitreal injection of 1.25 mg bevacizumab;
- Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose, a subconjunctival injection of 40 mg triamcinolone acetonide and an intravitreal injection of 1.25 mg bevacizumab.
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 postoperative.
The secondary endpoint is the occurrence of postoperative clinically significant macular edema (CSME) within 12 weeks postoperatively. Other study endpoints are mean CDVA in logMAR at 6 weeks and 12 weeks postoperatively; OCT measured average retinal thickness in the central inner circle (3mm), the outer circle (6mm), and the macular volume at 6 weeks and 12 weeks postoperatively; intraocular pressure at 6 weeks and 12 weeks postoperatively.
In case of clinically significant macular edema, treatment will be initiated and its effect will be part of the evaluation at 12 weeks. Medical data of all patients who develop macular edema during this study will be checked at least 6 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Non diabetics: bromfenac | Active comparator | Drug: Bromfenacbromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperatively |
| Non diabetics: dexamethasone | Active comparator | Drug: Dexamethasonedexamethasone 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 |
| Non diabetics: bromfenac & dexamethasone | Active comparator | Drug: Bromfenac, Drug: Dexamethasonebromfenac 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 |
| Diabetics: eye drops | Active comparator | Drug: Bromfenac, Drug: Dexamethasonebromfenac 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 |
| Diabetics: eye drops & TA | Active comparator | Drug: Bromfenac, Drug: Dexamethasone, Drug: Triamcinolone Acetonidebromfenac 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) |
| Diabetics: eye drops & bevacizumab | Active comparator | Drug: Bromfenac, Drug: Dexamethasone, Drug: Bevacizumabbromfenac 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) |
| Diabetics: eye drops, TA & bevacizumab | Active comparator | Drug: Bromfenac, Drug: Dexamethasone, Drug: Bevacizumab, Drug: Triamcinolone Acetonidebromfenac 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- 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.
- Exclusion criteria will be different for non-diabetic and diabetic patients. All ophthalmic exclusion criteria are applicable to the study eye only, unless stated otherwise.
Key exclusion criteria (0 listed)
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: EMEA/H/C/001198 | Drug | Diabetics: eye drops, Diabetics: eye drops & TA, Diabetics: eye drops & bevacizumab, Diabetics: eye drops, TA & bevacizumab, Non diabetics: bromfenac, Non diabetics: bromfenac & dexamethasone |
| DexamethasoneAlso: Dexamethasone ophthalmic solution, Product code (NL): RVG 56003 | Drug | Diabetics: eye drops, Diabetics: eye drops & TA, Diabetics: eye drops & bevacizumab, Diabetics: eye drops, TA & bevacizumab, Non diabetics: bromfenac & dexamethasone, Non diabetics: dexamethasone |
| BevacizumabAlso: Avastin, Product code: EU/1/04/300/002 | Drug | Diabetics: eye drops & bevacizumab, Diabetics: eye drops, TA & bevacizumab |
| Triamcinolone AcetonideAlso: Triesence or Vistrec, Product code (NL): RVG 106092 | Drug | Diabetics: eye drops & TA, Diabetics: eye drops, TA & bevacizumab |
Primary outcome
Change in central subfield mean macular thickness as a measurement of efficacy
Time frame: 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.
1 secondary outcome
No. of subjects developing clinically significant macular edema as a measurement of efficacy
Time frame: 12 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Derived from this study: PubMed 34417781Simons 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.
- Derived from this study: PubMed 33009281Simons 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.
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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.
prof. Rudy MM Nuijts, MD, PhD principal investigator
University Eye Clinic Maastricht, University Hospital Maastricht
16 sites in 7 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 Bevacizumab in people with Cystoid Macular Edema and Cataract, run by Maastricht University Medical Center at 16 sites in 7 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 35 inclusion and 0 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: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Netherlands, Austria, Belgium, Germany, Hungary and 2 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 6 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774474, which also lists 2 linked publications.
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 14 Apr 2017.