Trial · NCT04101721
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
NCT04101721, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2023-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity. Trials, record NCT04101721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04101721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
- NCT number
- NCT04101721
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 127 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Retinopathy of Prematurity
- Interventions
- aflibercept, laser photocoagulation
- First posted
- 2019-09-24
- Last updated
- 2023-07-20
- Other registries' IDs
- eudract:2019-001764-29
- Results first posted
- 2023-07-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age | Baseline to week 52 of chronological age | Active ROP was ROP requiring treatment and unfavorable structural outcome was defined as retinal detachment, macular dragging, macular fold, or retrolental opacity. For participants with both eyes enrolled in the study, both eyes must have met the endpoint. Participants with only one study eye enrolled were responders if the respective eye responded. |
| Secondary | Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age | Baseline to to week 52 of chronological age | Second treatment modality includes any treatment in addition to that assigned to the participant at baseline. This includes per-protocol rescue treatment (laser for aflibercept group, aflibercept for laser group), anti-VEGF agents not part of study protocol (e.g., bevacizumab, ranibizumab, commercially-available aflibercept not provided as study medication), or any ocular surgery for the management of any retinal pathology secondary to ROP (e.g., victrectomy, scleral buckle for retinal detachments). |
| Secondary | Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age | Baseline to week 52 of chronological age | Recurrence of disease is defined as the reappearance of the disease requiring further treatment (including retreatment or rescue), where both "presence of ROP" and "presence of active ROP requiring treatment" are marked as "Yes", after initial regression. Here, the initial regression is defined as, at a particular visit, absence of ROP or ROP treatment not required for active ROP, i.e., presence of ROP is marked as "No" or the presence of active ROP requiring treatment is marked as "No." |
| Secondary | Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Baseline to Week 52 of chronological age | |
| Secondary | Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs | Baseline to Week 52 of chronological age |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age | Baseline to week 52 of chronological age | Full analysis set (FAS): All randomized participants who received any study treatment. Analysis on the FAS was performed according to the treatment assigned at baseline (as randomized). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age | Baseline to to week 52 of chronological age | Full analysis set (FAS): All randomized participants who received any study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age | Baseline to week 52 of chronological age | Full analysis set (FAS): All randomized participants who received any study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Baseline to Week 52 of chronological age | Safety analysis set (SAF): All randomized participants who received any study treatment (active or laser); it is based on the treatment actually received (as treated). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs | Baseline to Week 52 of chronological age | Safety analysis set (SAF): All randomized participants who received any study treatment (active or laser); it is based on the treatment actually received (as treated). | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age | Laser Photocoagulation | 77.8 | Percentage of participants | ||
| Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age | Aflibercept 0.4 mg | 79.6 | Percentage of participants | ||
| Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age | Laser Photocoagulation | 18.5 | Percentage of participants | ||
| Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age | Aflibercept 0.4 mg | 15.1 | Percentage of participants | ||
| Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age | Laser Photocoagulation | 29.6 | Percentage of participants | ||
| Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age | Aflibercept 0.4 mg | 39.8 | Percentage of participants | ||
| Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Laser Photocoagulation | % Ocular TEAEs | 25.9 | Percentage of participants | |
| Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Aflibercept 0.4 mg | % Ocular TEAEs | 18.3 | Percentage of participants | |
| Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Laser Photocoagulation | % Ocular TESAEs | 11.1 | Percentage of participants | |
| Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Aflibercept 0.4 mg | % Ocular TESAEs | 6.5 | Percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Laser Photocoagulation | 27 | 50 |
| Overall Study | STARTED | Aflibercept 0.4 mg | 93 | 179 |
| Overall Study | COMPLETED | Laser Photocoagulation | 26 | 48 |
| Overall Study | COMPLETED | Aflibercept 0.4 mg | 87 | 168 |
| Overall Study | NOT COMPLETED | Laser Photocoagulation | 1 | 2 |
| Overall Study | NOT COMPLETED | Aflibercept 0.4 mg | 6 | 11 |
Source ClinicalTrials.gov
Adverse events124
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 | Constipation | Gastrointestinal disorders | Laser Photocoagulation | 4 | 27 | 5 |
| other | Constipation | Gastrointestinal disorders | Aflibercept 0.4 mg | 4 | 93 | 4 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Laser Photocoagulation | 2 | 27 | 2 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Aflibercept 0.4 mg | 5 | 93 | 5 |
| other | Inguinal hernia | Gastrointestinal disorders | Laser Photocoagulation | 3 | 27 | 3 |
| other | Inguinal hernia | Gastrointestinal disorders | Aflibercept 0.4 mg | 4 | 93 | 4 |
| other | Umbilical hernia | Gastrointestinal disorders | Laser Photocoagulation | 0 | 27 | 0 |
| other | Umbilical hernia | Gastrointestinal disorders | Aflibercept 0.4 mg | 5 | 93 | 5 |
| other | Pyrexia | General disorders | Laser Photocoagulation | 4 | 27 | 4 |
| other | Pyrexia | General disorders | Aflibercept 0.4 mg | 4 | 93 | 6 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Laser Photocoagulation | 0 | 27 |
| Total, all-cause mortality | Aflibercept 0.4 mg | 1 | 93 |
| Total, other adverse events | Laser Photocoagulation | 12 | 27 |
| Total, other adverse events | Aflibercept 0.4 mg | 40 | 93 |
| Total, serious adverse events | Laser Photocoagulation | 12 | 27 |
| Total, serious adverse events | Aflibercept 0.4 mg | 32 | 93 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Laser Photocoagulation vs Aflibercept 0.4 mg: deaths from any cause | Trial comparisons |
| Laser Photocoagulation vs Aflibercept 0.4 mg: 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/NCT04101721
GET https://conductscience.org/api/trials/v1/NCT04101721/events?page=2