Trial · NCT04004208
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Number of Participants With Potential Neutralizing Antibodies (NAb) | At 12 weeks after aflibercept injection | NAb status was evaluated for the samples that were positive in the ADA assay and had sufficient volume to analyze. NAb were only measured in participants with positive ADA in the Aflibercept 0.4 mg treatment arm |
| Secondary | Number of Aflibercept Administrations | From baseline (treatment) up to week 24. | Total number of injections in both eyes. |
| Secondary | Number of Laser Treatments | From baseline (treatment) up to week 24. | Total number of laser treatment in both eyes. If multiple sessions of laser treatment were necessary within 1 week from baseline, they were counted as a single treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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