Trial · NCT03610646
Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
NCT03610646, Phase 3, Completed, Mylan Pharmaceuticals Inc; results first posted 2023-03-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME). Trials, record NCT03610646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03610646
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
- NCT number
- NCT03610646
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 355 participants, actual
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Conditions
- Diabetic Macular Edema
- Interventions
- MYL-1701P, Eylea
- First posted
- 2018-08-01
- Last updated
- 2023-03-07
- Results first posted
- 2023-03-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | 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. |
| Secondary | The Mean Change From Baseline in Central Retinal Thickness (CRT) | From baseline to week 52 | The mean change from baseline in Central Retinal Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) over time |
| Secondary | The Mean Change in BCVA | From baseline to week 52 | 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 |
| Secondary | Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA | From baseline to week 52 | Number of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time |
| Secondary | Number of Administrations of Study Drug Required | From baseline to week 52 | The mean number of doses administered during the 52 weeks of study |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | From baseline to week 52 | Number of Participants with Treatment Emergent Adverse Events (Safety and tolerability) |
| Secondary | Number of Subjects With Induced and Boosted Anti-Drug Antibodies | From baseline to week 52 | Number of subjects with induced and boosted Anti-Drug Antibodies (ADA) (Immunogenicity) |
| Secondary | Concentration of Aflibercept in Blood (Pharmacokinetics) | 2 Days after Week 16 Injection | Free Drug Concentration of aflibercept in blood (Pharmacokinetics) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | Baseline and 8 weeks | The intention-to-treat (ITT) analysis set consists of all randomized subjects. | BCVA letter score | LEAST_SQUARES_MEAN |
| SECONDARY | The Mean Change From Baseline in Central Retinal Thickness (CRT) | From baseline to week 52 | The intention-to-treat (ITT) analysis set consists of all randomized subjects. | Micrometer | MEAN |
| SECONDARY | The Mean Change in BCVA | From baseline to week 52 | The intention-to-treat (ITT) analysis set consists of all randomized subjects. | BCVA letter score | MEAN |
| SECONDARY | Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA | From baseline to week 52 | All randomized subjects with last observation carried forward (LOCF) value at timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Administrations of Study Drug Required | From baseline to week 52 | The intention-to-treat (ITT) analysis set consists of all randomized subjects. | Doses | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events | From baseline to week 52 | Population consists of all subjects who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Induced and Boosted Anti-Drug Antibodies | From baseline to week 52 | All subjects who received at least one dose of study drug and have baseline and at least one post-baseline ADA results. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Concentration of Aflibercept in Blood (Pharmacokinetics) | 2 Days after Week 16 Injection | All subjects who have signed the Informed Consent Form (ICF) for participation in Pharmacokinetics (PK) subpopulation and have at least one measured concentration of study treatment. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | MYL-1701P | 6.60 | Standard Error 0.548 | BCVA letter score | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | Eylea | 6.56 | Standard Error 0.548 | BCVA letter score | |
| The Mean Change From Baseline in Central Retinal Thickness (CRT) | MYL-1701P | -170.14 | Standard Error 7.198 | Micrometer | |
| The Mean Change From Baseline in Central Retinal Thickness (CRT) | Eylea | -167.67 | Standard Error 7.260 | Micrometer | |
| The Mean Change in BCVA | MYL-1701P | 10.76 | Standard Error 0.619 | BCVA letter score | |
| The Mean Change in BCVA | Eylea | 10.52 | Standard Error 0.621 | BCVA letter score | |
| Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA | MYL-1701P | 57 | Participants | ||
| Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA | Eylea | 51 | Participants | ||
| Number of Administrations of Study Drug Required | MYL-1701P | 8.4 | Standard Deviation 2.06 | Doses | |
| Number of Administrations of Study Drug Required | Eylea | 8.7 | Standard Deviation 1.76 | Doses |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MYL-1701P | 179 | |
| Overall Study | STARTED | Eylea | 176 | |
| Overall Study | Treated | MYL-1701P | 178 | |
| Overall Study | Treated | Eylea | 176 | |
| Overall Study | COMPLETED | MYL-1701P | 161 | |
| Overall Study | COMPLETED | Eylea | 158 | |
| Overall Study | NOT COMPLETED | MYL-1701P | 18 | |
| Overall Study | NOT COMPLETED | Eylea | 18 |
Source ClinicalTrials.gov
Adverse events130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract | Eye disorders | MYL-1701P | 12 | 178 | 17 |
| other | Cataract | Eye disorders | Eylea | 12 | 176 | 12 |
| other | Diabetic retinal oedema | Eye disorders | MYL-1701P | 9 | 178 | 9 |
| other | Diabetic retinal oedema | Eye disorders | Eylea | 10 | 176 | 13 |
| other | Nasopharyngitis | Infections and infestations | MYL-1701P | 14 | 178 | 19 |
| other | Nasopharyngitis | Infections and infestations | Eylea | 10 | 176 | 10 |
| other | Diabetes mellitus | Metabolism and nutrition disorders | MYL-1701P | 2 | 178 | 3 |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Eylea | 9 | 176 | 10 |
| other | Hypertension | Vascular disorders | MYL-1701P | 16 | 178 | 20 |
| other | Hypertension | Vascular disorders | Eylea | 20 | 176 | 23 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MYL-1701P | 2 | 178 |
| Total, all-cause mortality | Eylea | 4 | 176 |
| Total, other adverse events | MYL-1701P | 53 | 178 |
| Total, other adverse events | Eylea | 61 | 176 |
| Total, serious adverse events | MYL-1701P | 31 | 178 |
| Total, serious adverse events | Eylea | 23 | 176 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MYL-1701P vs Eylea: Number of Subjects With Induced and Boosted Anti-Drug Antibodies | Trial comparisons |
| MYL-1701P vs Eylea: Number of Participants With Treatment Emergent Adverse Events | Trial comparisons |
| MYL-1701P vs Eylea: Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA | Trial comparisons |
| MYL-1701P vs Eylea: deaths from any cause | Trial comparisons |
| MYL-1701P vs Eylea: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03610646
GET https://conductscience.org/api/trials/v1/NCT03610646/events?page=2