Diabetic Macular EdemaPhase 3DMENCT03610646
Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
A Phase 3 study testing MYL-1701P and Eylea in people with Diabetic Macular Edema, run by Mylan Pharmaceuticals Inc at 73 sites in 9 countries.
Trial summary
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- MYL-1701P and Eylea
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 73 sitesin 9 countries
- Study dates
- 23 Aug 2018to 10 Sep 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects age ≥ 18 years.
- Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
- The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
- Subject is able to understand and voluntarily provide written informed consent to participate in the study.
- If female of child bearing potential, the subject must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at baseline visit, and should not be nursing or planning a pregnancy.
- If female, subject must be:
Show all 11Show fewer
- Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
- Of childbearing potential and practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing and continuing at least 90 days following the last treatment.
- Of non-childbearing potential (i.e., postmenopausal for at least 1 year).
- If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control with sexual partner (as described in inclusion criteria #6b of protocol) or abstain from sexual relations during the study period and up to 90 days following the last treatment dose.
- Subject is willing to comply with the study duration, study visits and study related procedures.
Who cannot join
- Subjects with known hypersensitivity to aflibercept or any of the excipients
- Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
- Subjects with uncontrolled hypertension defined as systolic blood pressure >160mm Hg or diastolic blood pressure > 95 mm of Hg.
- Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
- Subjects with history of use of intraocular corticosteroids anytime in the past or periocular (subconjunctival, intra-scleral, sub-tenon or retrobulbar) corticosteroids within 4 months of randomization
- Subjects who have only one functional eye, even if the eye met all other study requirements, or who have an ocular condition on the fellow eye with a poorer prognosis than the study eye.
Trial locations and contacts
73 sites in 9 countries.
73 sites in 9 countries
India15 sites
Mylan Investigator Site
Ahmedabad, Gujarat, 380015
Mylan Investigator Site
Ahmedabad, Gujarat, 380016
Mylan Investigator Site
Bangalore, Karnataka, 560010
Mylan Investigator site
Bangalore, Karnataka, 560037
Mylan Investigator Site
Bangalore, Karnataka, 560094
Mylan Investigator Site
Bhubaneswar, Odisha, 751024
Mylan Investigator Site
Chandigarh, Punjab, 160012
Mylan Investigator Site
Hyderabad, Telangana, 500034
Mylan Investigator Site
Jaipur, Rajasthan, 302015
Mylan Investigator Site
Madurai, Tamil Nadu, 625020
Mylan Investigator Site
Mumbai, Maharashtra, 400050
Mylan Investigator Site
New Delhi, National Capital Territory of Delhi, 110029
Mylan Investigator Site
Noida, Uttar Pradesh, 201301
Mylan Investigator Site
Tirunelveli, Tamil Nadu, 627002
Mylan Investigator Site
Visakhapatnam, Andhra Pradesh, 530040
Japan14 sites
Mylan Investigator Site
Fukuoka, 8110213
Mylan Investigator Site
Fukushima, 9601295
Mylan Investigator Site
Kagoshima, 8920824
Mylan Investigator Site
Kofu, Yamanashi, 4008506
Mylan Investigator Site
Kōriyama, Fukushima, 9638052
Mylan Investigator Site
Kumamoto, 8600027
Mylan Investigator Site
Mito, Ibaraki, 3100845
Mylan Investigator Site
Nagasaki, 8528501
Mylan Investigator Site
Nagoya, Aichi-ken, 4578510
National Hospital Organization Osaka National Hospital
Osaka, 5400006
Mylan Investigator Site
Saitama, 3308553
Mylan Investigator Site
Sapporo, Hokkaido, 0608604
Mylan Investigator Site
Susono, Shizuoka, 4101102
Mylan Investigator Site
Yamato, Kanagawa, 2420001
United States13 sites
Mylan Investigator Site
Abilene, Texas, 79606
Mylan Investigator Site
Augusta, Georgia, 30909
Mylan Investigator Site
Chevy Chase, Maryland, 20815
Mylan Investigator Site
Ladson, South Carolina, 29456
Mylan Investigator Site
Morgantown, West Virginia, 26506
Mylan Investigator Site
Nashville, Tennessee, 37203
Mylan Investigator Site
Paducah, Kentucky, 42001
Mylan Investigator Site
Phoenix, Arizona, 85014
Mylan Investigator Site
Phoenix, Arizona, 85020
Mylan Investigator Site
Sacramento, California, 95841
Mylan Investigator Site
Shawnee Mission, Kansas, 66204
Mylan Investigator Site
St. Petersburg, Florida, 33711
Mylan Investigator Site
Winter Haven, Florida, 33880
Czechia7 sites
Mylan Investigator Site
Hradec Králové, 50005
Mylan Investigator Site
Olomouc, 77900
Mylan Investigator Site
Pardubice, 53002
Mylan Investigator Site
Prague, Vinohrady, 10034
Mylan Investigator Site
Prague, 12808
Mylan Investigator Site
Prague, 15000
Mylan Investigator Site
Zlín, 76275
Hungary7 sites
Mylan Investigator Site
Budapest, 1076
Mylan Investigator Site
Budapest, 1106
Mylan Investigator Site
Debrecen, 4032
Mylan Investigator Site
Nyíregyháza, 4400
Mylan Investigator Site
Pécs, 7621
Mylan Investigator Site
Szeged, 6720
Mylan Investigator Site
Zalaegerszeg, 8900
Poland6 sites
Mylan Investigator Site
Katowice, Silesian Voivodeship, 40594
Mylan Investigator Site
Lodz, Łódź Voivodeship, 91134
Mylan Investigator Site
Olsztyn, Warmian-Masurian Voivodeship, 10424
Mylan Investigator Site
Rzeszów, 35017
Mylan Investigator Site
Tarnów, Tarnow, 33100
Mylan Investigator Site
Wałbrzych, 58309
Russia5 sites
Mylan Investigator Site
Kazan', Tatarstan Resp., 420012
Mylan Investigator Site
Moscow, 119021
Mylan Investigator Site
Novosibirsk, 630096
Mylan Investigator Site
Omsk, 644042
Mylan Investigator Site
Saint Petersburg, 197022
Germany3 sites
Mylan Investigator Site
Göttingen, Lower Saxony, 37075
Mylan Investigator Site
Mainz, Rheinland-Pflaz, 55131
Mylan Investigator Site
Marburg, 35043
Latvia3 sites
Mylan Investigator Site
Jelgava, LV-3001
Mylan Investigator Site
Riga, LV-1002
Mylan Investigator Site
Riga, LV-1006
About this study
Official title: A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®.
The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.
Read the detailed description
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Subjects to receive the assigned treatment until Week 48.
All subjects to return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. Additional visits allowed during the study as specified in the study schedule for safety and pharmacokinetic evaluation.
Pharmacokinetics (PK) and Immunogenicity to be assessed in the subjects participating in the study.
- Conditions
- Diabetic Macular Edema
- Being tested
- MYL-1701P, Eylea
- Keywords
- Diabetic Macular Edema,, BCVA,, ETDRS Letters.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYL-1701PDrug
Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks.
The additional doses may be administered in accordance with the protocol.
EyleaDrug
Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks.
The additional doses may be administered in accordance with the protocol.
| Study group | Role | What they receive |
|---|---|---|
| MYL-1701P | Experimental | MYL-1701P Receives: Drug: MYL-1701P |
| Eylea | Active comparator | Eylea Receives: Drug: Eylea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8.
Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Measured: Baseline and 8 weeks
Secondary outcomes (7)
The Mean Change From Baseline in Central Retinal Thickness (CRT)
The mean change from baseline in Central Retinal Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) over time
Measured: From baseline to week 52
The Mean Change in BCVA
Mean change from baseline in BCVA as assessed by ETDRS letters over time. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening
Measured: From baseline to week 52
Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA
Number of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time
Measured: From baseline to week 52
Number of Administrations of Study Drug Required
The mean number of doses administered during the 52 weeks of study
Measured: From baseline to week 52
Number of Participants With Treatment Emergent Adverse Events
Number of Participants with Treatment Emergent Adverse Events (Safety and tolerability)
Measured: From baseline to week 52
Number of Subjects With Induced and Boosted Anti-Drug Antibodies
Number of subjects with induced and boosted Anti-Drug Antibodies (ADA) (Immunogenicity)
Measured: From baseline to week 52
Concentration of Aflibercept in Blood (Pharmacokinetics)
Free Drug Concentration of aflibercept in blood (Pharmacokinetics)
Measured: 2 Days after Week 16 Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start23 Aug 2018
- Primary completion10 Nov 2020
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either MYL-1701P or Eylea groups in parallel for the duration of the study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Momenta Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610646
- Sponsor's protocol ID
- MYL-1701P-3001
- Acronym
- DME
- Status last verified
- Feb 2023
- First submitted
- 9 Jul 2018
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chauhan R, Gupta V, Natesh S, Vohra R, Agarwal V, Ganapathi PC, Bose D, Loganathan S. Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial. BMJ Open Ophthalmol. 2026 Jun 29;11(2):e002637. doi: 10.1136/bmjophth-2025-002637.
PubMed 42373197Bressler SB, Oleksy P, Alfaro DV, Apte RS, Barve A, Baumane K, Beckmann K, Degi R, Ernest J, Gupta V, Kamei M, Kishino G, Lorenz K, Marcus DM, Bose D, Ganapathi PC, Loganathan S. Comparability of aflibercept biosimilar with reference aflibercept in diabetic macular edema: subgroup analysis of the pivotal Phase-III INSIGHT randomized clinical trial. Expert Opin Biol Ther. 2026 May;26(5):525-534. doi: 10.1080/14712598.2026.2672422. Epub 2026 May 18.
PubMed 42104207Bressler SB, Barve A, Ganapathi PC, Beckmann K, Apte RS, Marcus DM, Baumane K, Agarwal S, Oleksy P, Reichstein DA, Patel SS, Ernest J, Degi R, Gupta V, Kishino G, Kamei M, Loganathan S; INSIGHT Study Group. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial. JAMA Ophthalmol. 2024 Oct 1;142(10):952-960. doi: 10.1001/jamaophthalmol.2024.3458.
PubMed 39264599
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT03610646
- Acronym / sponsor ID
- DME / MYL-1701P-3001
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema,, BCVA,, ETDRS Letters.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Collaborators
- Momenta Pharmaceuticals, Inc.
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®.
The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.
Detailed description
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Subjects to receive the assigned treatment until Week 48.
All subjects to return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. Additional visits allowed during the study as specified in the study schedule for safety and pharmacokinetic evaluation.
Pharmacokinetics (PK) and Immunogenicity to be assessed in the subjects participating in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to either MYL-1701P or Eylea groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| MYL-1701P | Experimental | Drug: MYL-1701PMYL-1701P |
| Eylea | Active comparator | Drug: EyleaEylea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects age ≥ 18 years.
- Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
- The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
- Subject is able to understand and voluntarily provide written informed consent to participate in the study.
- If female of child bearing potential, the subject must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at baseline visit, and should not be nursing or planning a pregnancy.
Key exclusion criteria (6 listed)
- Subjects with known hypersensitivity to aflibercept or any of the excipients
- Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
- Subjects with uncontrolled hypertension defined as systolic blood pressure >160mm Hg or diastolic blood pressure > 95 mm of Hg.
- Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
- Subjects with history of use of intraocular corticosteroids anytime in the past or periocular (subconjunctival, intra-scleral, sub-tenon or retrobulbar) corticosteroids within 4 months of randomization
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 |
|---|---|---|
| MYL-1701PSubjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol. | Drug | MYL-1701P |
| EyleaSubjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol. | Drug | Eylea |
Primary outcome
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
Time frame: Baseline and 8 weeks
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
7 secondary outcomes
The Mean Change From Baseline in Central Retinal Thickness (CRT)
Time frame: From baseline to week 52
The Mean Change in BCVA
Time frame: From baseline to week 52
Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA
Time frame: From baseline to week 52
Number of Administrations of Study Drug Required
Time frame: From baseline to week 52
Number of Participants With Treatment Emergent Adverse Events
Time frame: From baseline to week 52
Number of Subjects With Induced and Boosted Anti-Drug Antibodies
Time frame: From baseline to week 52
Concentration of Aflibercept in Blood (Pharmacokinetics)
Time frame: 2 Days after Week 16 Injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42373197Chauhan R, Gupta V, Natesh S, Vohra R, Agarwal V, Ganapathi PC, Bose D, Loganathan S. Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial. BMJ Open Ophthalmol. 2026 Jun 29;11(2):e002637. doi: 10.1136/bmjophth-2025-002637.
- Derived from this study: PubMed 42104207Bressler SB, Oleksy P, Alfaro DV, Apte RS, Barve A, Baumane K, Beckmann K, Degi R, Ernest J, Gupta V, Kamei M, Kishino G, Lorenz K, Marcus DM, Bose D, Ganapathi PC, Loganathan S. Comparability of aflibercept biosimilar with reference aflibercept in diabetic macular edema: subgroup analysis of the pivotal Phase-III INSIGHT randomized clinical trial. Expert Opin Biol Ther. 2026 May;26(5):525-534. doi: 10.1080/14712598.2026.2672422. Epub 2026 May 18.
- Derived from this study: PubMed 39264599Bressler SB, Barve A, Ganapathi PC, Beckmann K, Apte RS, Marcus DM, Baumane K, Agarwal S, Oleksy P, Reichstein DA, Patel SS, Ernest J, Degi R, Gupta V, Kishino G, Kamei M, Loganathan S; INSIGHT Study Group. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial. JAMA Ophthalmol. 2024 Oct 1;142(10):952-960. doi: 10.1001/jamaophthalmol.2024.3458.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
73 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MYL-1701P and Eylea in people with Diabetic Macular Edema, run by Mylan Pharmaceuticals Inc at 73 sites in 9 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 11 inclusion and 6 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 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in India, Japan, United States, Czechia, Hungary and 4 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?
Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 (time frame: Baseline and 8 weeks). 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 NCT03610646, which also lists 3 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 7 Mar 2023.