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
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:
Show all 10Show fewer
- 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.
Show all 12Show fewer
- 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