Diabetic Macular EdemaPhase 3NCT04674800
Extension Study of MYL-1701P-3001 for Safety and Efficacy
A Phase 3 study testing MYL-1701P, a proposed biosimilar to Eylea in people with Diabetic Macular Edema, run by Mylan Pharmaceuticals Inc at 15 sites in India.
Trial summary
This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 (NCT03610646) study. 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, a proposed biosimilar to Eylea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 15 sitesIndia
- Study dates
- 23 Nov 2020to 20 Apr 2022
- 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
- Subject participated in the MYL-1701P-3001 study
- Subject requires treatment with intravitreal anti-VEGF therapy
- Subject is able to understand and voluntarily provide written informed consent to participate in the study.
- If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy.
- Subject is willing to comply with the study duration, study visits and study related procedures.
- If female, subject must be:
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- Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
- Of childbearing potential and practicing an acceptable form of birth control
- Of non-childbearing potential
- If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control
Who cannot join
- Subjects with known hypersensitivity to aflibercept or any of the excipients
- Subjects will be excluded if any of the following conditions are met in the study eye:
- Subjects with active ocular inflammation.
- Subjects with uncontrolled glaucoma
- Surgery for glaucoma in the past or likely to be needed in the future.
- Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
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- Subjects who plan to participate in another clinical study while enrolled in this study.
- Subjects receiving treatment for a serious systemic infection.
- Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg.
- Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment.
- Subjects with renal failure requiring dialysis or renal transplant.
- Subjects with a history or presence of any clinically significant condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
India15 sites
Mylan Investigative Site
Ahmedabad, Gujarat, 380015
Mylan Investigative site
Ahmedabad, Gujarat, 380016
Mylan Investigative site
Bangalore, Karnataka, 560 010
Mylan Investigative Site
Bangalore, Karnataka, 560094
Mylan Investigative Site
Bengaluru, Karnataka, 560037
Mylan Investigative site
Bhubaneswar, Odisha, 751024
Mylan Investigative Site
Chandigarh, Punjab, 160012
Mylan Investigative site
Hyderabad, Andhra Pradesh, 500034
Mylan Investigative site
Jaipur, Rajasthan, 302015
Mylan Investigative site
Madurai, Tamil Nadu, 625 020
Mylan Investigative Site
Mumbai, Maharashtra, 400050
Mylan Investigative site
New Delhi, New Delhi, 110029
Mylan Investigative Site
Noida, Uttar Pradesh, 201301
Mylan Investigative site
Tirunelveli, Tamil Nadu, 627002
Mylan Investigative Site
Visakhapatnam, Andhra Pradesh, 530 040
About this study
Official title: A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.
This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 (NCT03610646) study.
Read the detailed description
Diabetic retinopathy is an important cause of blindness worldwide. The International Diabetes Federation estimates that 285 million people worldwide have diabetes mellitus and approximately 7% of these individuals are affected by diabetic macular edema.
EYLEA® (aflibercept) injection, an anti-Vascular Endothelial Growth Factor (VEGF) agent, has been approved by the FDA and EMA for the treatment of Diabetic Macular Edema (DME).
Mylan Inc. and Momenta Pharmaceuticals, Inc. are developing MYL-1701P, a proposed biosimilar to Eylea.
MYL-1701P-3001 (NCT03610646) study was designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of MYL-1701P in the treatment of subjects with Diabetic Macular Edema (DME). Eligible subjects from MYL-1701P-3001 (NCT03610646) study will be enrolled in the AFIL-IJZ-3002 study. All enrolled subjects will receive three doses of MYL-1701P every eight weeks. Subjects will attend the clinic visits for safety and efficacy assessments including Best Corrected Visual Acuity (BCVA), Spectral domain- Optical Coherence Tomography (SD-OCT), complete ophthalmological examinations during the study.
- Conditions
- Diabetic Macular Edema
- Being tested
- MYL-1701P, a proposed biosimilar to 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-1701P, a proposed biosimilar to EyleaBiological
MYL-1701P- 3 doses each of 2 mg at 8 weeks interval
| Study group | Role | What they receive |
|---|---|---|
| Single, test arm | Experimental | Open label, single arm study Receives: Biological: MYL-1701P, a proposed biosimilar to Eylea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs).
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
Measured: Week 20
Secondary outcomes (6)
Change From Baseline in BCVA at Week 8
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Measured: Week 8
Change From Baseline in CRT at Week 8
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Measured: Weeks 8
Change From Baseline in BCVA at Week 16
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Measured: Week 16
Change From Baseline in BCVA at Week 20
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Measured: Week 20
Change From Baseline in CRT at Week 16
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Measured: Week 16
Change From Baseline in CRT at Week 20
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start23 Nov 2020
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
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 (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Momenta Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Prasanna Ganapathi, MD, Study director, Mylan Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674800
- Sponsor's protocol ID
- AFIL-IJZ-3002
- Status last verified
- Jul 2026
- First submitted
- 30 Nov 2020
- Last updated
- 3 Aug 2026
- 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 42373197
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.
- ClinicalTrials.gov ID
- NCT04674800
- Acronym / sponsor ID
- AFIL-IJZ-3002
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, BCVA, ETDRS Letters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Collaborators
- Momenta Pharmaceuticals, Inc.
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Posted 3 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 (NCT03610646) study.
Detailed description
Diabetic retinopathy is an important cause of blindness worldwide. The International Diabetes Federation estimates that 285 million people worldwide have diabetes mellitus and approximately 7% of these individuals are affected by diabetic macular edema.
EYLEA® (aflibercept) injection, an anti-Vascular Endothelial Growth Factor (VEGF) agent, has been approved by the FDA and EMA for the treatment of Diabetic Macular Edema (DME).
Mylan Inc. and Momenta Pharmaceuticals, Inc. are developing MYL-1701P, a proposed biosimilar to Eylea.
MYL-1701P-3001 (NCT03610646) study was designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of MYL-1701P in the treatment of subjects with Diabetic Macular Edema (DME). Eligible subjects from MYL-1701P-3001 (NCT03610646) study will be enrolled in the AFIL-IJZ-3002 study. All enrolled subjects will receive three doses of MYL-1701P every eight weeks. Subjects will attend the clinic visits for safety and efficacy assessments including Best Corrected Visual Acuity (BCVA), Spectral domain- Optical Coherence Tomography (SD-OCT), complete ophthalmological examinations during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single, test arm | Experimental | Biological: MYL-1701P, a proposed biosimilar to EyleaOpen label, single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject participated in the MYL-1701P-3001 study
- Subject requires treatment with intravitreal anti-VEGF therapy
- Subject is able to understand and voluntarily provide written informed consent to participate in the study.
- If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy.
- Subject is willing to comply with the study duration, study visits and study related procedures.
Key exclusion criteria (12 listed)
- Subjects with known hypersensitivity to aflibercept or any of the excipients
- Subjects will be excluded if any of the following conditions are met in the study eye:
- Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
- Subjects who plan to participate in another clinical study while enrolled in this study.
- Subjects receiving treatment for a serious systemic infection.
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-1701P, a proposed biosimilar to EyleaMYL-1701P- 3 doses each of 2 mg at 8 weeks interval | Biological | Single, test arm |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs).
Time frame: Week 20
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
6 secondary outcomes
Change From Baseline in BCVA at Week 8
Time frame: Week 8
Change From Baseline in CRT at Week 8
Time frame: Weeks 8
Change From Baseline in BCVA at Week 16
Time frame: Week 16
Change From Baseline in BCVA at Week 20
Time frame: Week 20
Change From Baseline in CRT at Week 16
Time frame: Week 16
Change From Baseline in CRT at Week 20
Time frame: Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- 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.
- Individual participant dataSharing planned: No
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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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.
Prasanna Ganapathi, MD study director
Mylan Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MYL-1701P, a proposed biosimilar to Eylea in people with Diabetic Macular Edema, run by Mylan Pharmaceuticals Inc at 15 sites in India.
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 10 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: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in India. 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 3 Aug 2026). 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?
Incidence of Treatment Emergent Adverse Events (TEAEs). (time frame: Week 20). 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 NCT04674800, which also lists 1 linked publication.
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 3 Aug 2026.