Trial · NCT04004208
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
NCT04004208, Phase 3, Completed, Bayer; results first posted 2022-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy. Trials, record NCT04004208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04004208
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
- NCT number
- NCT04004208
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 113 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Retinopathy of Prematurity (ROP)
- Interventions
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- First posted
- 2019-07-01
- Last updated
- 2022-05-06
- Other registries' IDs
- eudract:2018-002611-99
- Results first posted
- 2022-05-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes | At 24 weeks after starting study treatment | Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity. |
| Secondary | Proportion of Participants Requiring Intervention With a Second Treatment Modality | From baseline (treatment) up to week 24. | A second treatment modality for ROP was either rescue treatment or any other surgical or nonsurgical treatment for ROP (e.g. IVT anti-VEGF injection, ablative laser therapy, cryotherapy, or vitrectomy) captured as concomitant medication or surgery after study start. |
| Secondary | Proportion of Participants With Recurrence of ROP | From baseline (treatment) up to week 24. | Participants with recurrence of ROP were defined as subjects requiring re-treatment or rescue treatment after in the past the absence of treatment-requiring active ROP had been confirmed by the investigator. |
| Secondary | Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium | From baseline (treatment) up to week 24. | Eyes were evaluated for change in ROP activity scale proposed by the International Neonatal Consortium (2018). ROP Activity Scale value range is from 0 to 22. Value 0 to 7 are considered mild, 8 to 12 are moderate, and 13 to 22 are severe. Value 0 means the best and value 22 means the worst. Eyes evaluation was done at baseline and each visit. |
| Secondary | Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) | From baseline (treatment) up to week 24 | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular TEAEs in treated eyes only were reported |
| Secondary | Percentage of Participants With Ocular Serious Adverse Events (SAEs) | From baseline (treatment) up to week 24 | Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular SAEs in treated eyes only were reported. |
| Secondary | Percentage of Participants With Systemic TEAEs | From baseline (treatment) up to week 24 | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic TEAEs only were reported. |
| Secondary | Percentage of Participants With Systemic SAEs | From baseline (treatment) up to week 24 | Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic SAEs only were reported. |
| Secondary | Concentrations of Free Aflibercept in Plasma | From Day 1 up to week 24. | Blood samples for determination of aflibercept concentrations in plasma were collected in the aflibercept 0.4 mg arm at Day 1 (within 24 hours after injection), and at weeks 2 and 4, and if feasible also at weeks 8, 12 and 24. Statistics for week 8, 12, 24 not calculated as \> 1/3 of the concentrations were below the lower limit of quantification. Free Aflibercept Concentrations in Plasma were only measured in the Aflibercept 0.4 mg treatment arm. |
| Secondary | Number of Participants With Anti-drug Antibodies (ADA) | Baseline (treatment) and 12 weeks after aflibercept injection | Immunogenicity was characterized by anti-drug antibody (ADA) responses in patients in the aflibercept 0.4 mg arm. Serum samples were taken at baseline prior to the injection and at 12 weeks after injection. ADA titers were summarized for 3 categories: Low (titer \<1,000); Moderate (1,000 ≤ titer ≤ 10,000); High (titer \>10,000). ADA in serum were only measured in the Aflibercept 0.4 mg treatment arm. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes | At 24 weeks after starting study treatment | Proportion of participants | NUMBER | |
| SECONDARY | Proportion of Participants Requiring Intervention With a Second Treatment Modality | From baseline (treatment) up to week 24. | Proportion of participants | NUMBER | |
| SECONDARY | Proportion of Participants With Recurrence of ROP | From baseline (treatment) up to week 24. | Proportion of participants | NUMBER | |
| SECONDARY | Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium | From baseline (treatment) up to week 24. | Scores on a scale | MEAN | |
| SECONDARY | Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) | From baseline (treatment) up to week 24 | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Ocular Serious Adverse Events (SAEs) | From baseline (treatment) up to week 24 | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Systemic TEAEs | From baseline (treatment) up to week 24 | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Systemic SAEs | From baseline (treatment) up to week 24 | Percentage of participants | NUMBER | |
| SECONDARY | Concentrations of Free Aflibercept in Plasma | From Day 1 up to week 24. | The outcome measure was analyzed based on pharmacokinetic analysis set (PKS). The PKS included all participants who received aflibercept treatment at the baseline visit and who had at least one nonmissing PK assessment following the first dose of study drug. | ng/mL | MEAN |
| SECONDARY | Number of Participants With Anti-drug Antibodies (ADA) | Baseline (treatment) and 12 weeks after aflibercept injection | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes | Aflibercept 0.4 mg | 0.855 | Proportion of participants | ||
| Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes | Laser Photocoagulation | 0.821 | Proportion of participants | ||
| Proportion of Participants Requiring Intervention With a Second Treatment Modality | Aflibercept 0.4 mg | 0.072 | Proportion of participants | ||
| Proportion of Participants Requiring Intervention With a Second Treatment Modality | Laser Photocoagulation | 0.096 | Proportion of participants | ||
| Proportion of Participants With Recurrence of ROP | Aflibercept 0.4 mg | 0.161 | Proportion of participants | ||
| Proportion of Participants With Recurrence of ROP | Laser Photocoagulation | 0.063 | Proportion of participants | ||
| Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium | Aflibercept 0.4 mg | Baseline | 16.20 | Standard Deviation 2.81 | Scores on a scale |
| Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium | Laser Photocoagulation | Baseline | 15.63 | Standard Deviation 3.53 | Scores on a scale |
| Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium | Aflibercept 0.4 mg | Change from baseline to Week 24 | -15.42 | Standard Deviation 4.46 | Scores on a scale |
| Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium | Laser Photocoagulation | Change from baseline to Week 24 | -14.77 | Standard Deviation 4.19 | Scores on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aflibercept 0.4 mg | 75 | |
| Overall Study | STARTED | Laser Photocoagulation | 38 | |
| Overall Study | SAF | Aflibercept 0.4 mg | 75 | |
| Overall Study | SAF | Laser Photocoagulation | 38 | |
| Overall Study | PKS | Aflibercept 0.4 mg | 75 | |
| Overall Study | PKS | Laser Photocoagulation | 0 | |
| Overall Study | AAS | Aflibercept 0.4 mg | 75 | |
| Overall Study | AAS | Laser Photocoagulation | 0 | |
| Overall Study | COMPLETED | Aflibercept 0.4 mg | 68 | |
| Overall Study | COMPLETED | Laser Photocoagulation | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events256
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 | Anaemia | Blood and lymphatic system disorders | Aflibercept 0.4 mg | 1 | 75 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Laser Photocoagulation | 2 | 38 | 3 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Aflibercept 0.4 mg | 0 | 75 | 0 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Laser Photocoagulation | 2 | 38 | 2 |
| other | Splenomegaly | Blood and lymphatic system disorders | Aflibercept 0.4 mg | 1 | 75 | 1 |
| other | Splenomegaly | Blood and lymphatic system disorders | Laser Photocoagulation | 0 | 38 | 0 |
| other | Bradycardia | Cardiac disorders | Aflibercept 0.4 mg | 2 | 75 | 2 |
| other | Bradycardia | Cardiac disorders | Laser Photocoagulation | 0 | 38 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Aflibercept 0.4 mg | 1 | 75 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Laser Photocoagulation | 0 | 38 | 0 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept 0.4 mg | 3 | 75 |
| Total, all-cause mortality | Laser Photocoagulation | 0 | 38 |
| Total, other adverse events | Aflibercept 0.4 mg | 53 | 75 |
| Total, other adverse events | Laser Photocoagulation | 23 | 38 |
| Total, serious adverse events | Aflibercept 0.4 mg | 9 | 75 |
| Total, serious adverse events | Laser Photocoagulation | 10 | 38 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aflibercept 0.4 mg vs Laser Photocoagulation: deaths from any cause | Trial comparisons |
| Aflibercept 0.4 mg vs Laser Photocoagulation: 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/NCT04004208
GET https://conductscience.org/api/trials/v1/NCT04004208/results?page=2