Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, BCVA, ETDRS Letters
Brief 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.
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.
Interventions
BIOLOGICALMYL-1701P, a proposed biosimilar to Eylea
MYL-1701P- 3 doses each of 2 mg at 8 weeks interval
Sponsors
Mylan Pharmaceuticals Inc
Momenta Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject participated in the MYL-1701P-3001 study 2. Subject requires treatment with intravitreal anti-VEGF therapy 3. Subject is able to understand and voluntarily provide written informed consent to participate in the study. 4. If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy. 5. Subject is willing to comply with the study duration, study visits and study related procedures. 6. If female, subject must be: * 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 7. If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control
Exclusion criteria
1. Subjects with known hypersensitivity to aflibercept or any of the excipients 2. 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. 3. Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye. 4. Subjects who plan to participate in another clinical study while enrolled in this study. 5. Subjects receiving treatment for a serious systemic infection. 6. Subjects with uncontrolled hypertension defined as systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 95 mm Hg. 7. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment. 8. Subjects with renal failure requiring dialysis or renal transplant. 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA at Week 8 | Week 8 | Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS) |
| Change From Baseline in CRT at Week 8 | Weeks 8 | Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT) |
| Change From Baseline in BCVA at Week 16 | Week 16 | Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS) |
| Change From Baseline in BCVA at Week 20 | Week 20 | Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS) |
| Change From Baseline in CRT at Week 16 | Week 16 | Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT) |
| Change From Baseline in CRT at Week 20 | Week 20 | Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT) |
Countries
India
Contacts
STUDY_DIRECTORPrasanna Ganapathi, MD
Mylan Inc.
Participant flow
Recruitment details
Parent study (MYL-1701P-3001) was designed to demonstrate the clinical similarity of MYL 1701P and Eylea regarding efficacy, safety, pharmacokinetics, and immunogenicity in the treatment of subjects with DME. AFIL-IJZ-3002 study was designed and conducted by Mylan to further evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of subjects who successfully completed the parent study MYL-1701P-3001.
Pre-assignment details
The extension study was open for all subjects from India who completed the parent study MYL-1701P-3001.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Best Corrected Visual Acuity | 70.6 Letters STANDARD_DEVIATION 14.1 |
| Corneal Retinal Thickness | 318.7 micrometers STANDARD_DEVIATION 132.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 52 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment India | 52 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 16 / 52 |
| serious Total, serious adverse events | 1 / 52 |
Outcome results
None listed