Trial · NCT05850520
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 36 | At Week 36 | BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity) |
| Secondary | Number of Active Injections From Baseline to Week 64 | From baseline to Week 64 | Active injections refer to the number of injections that were actually administered, as opposed to the number of planned injections. |
| Secondary | Number of Active Injections From Baseline to Week 36 | From baseline to Week 36 | Active injections refer to the number of injections that were actually administered, as opposed to the number of planned injections. |
| Secondary | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 44* | At Week 44 | BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity). \*This endpoint was only measured for the 8q8/5 and 2q4 groups |
| Secondary | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 64 | At Week 64 | BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity) |
| Secondary | Participants Gaining at Least 15 Letters in BCVA From Baseline at Weeks 36 and 64 | From baseline at Weeks 36 and 64 | |
| Secondary | Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Weeks 36 and 64 | At Weeks 36 and 64 | ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity) |
| Secondary | Participants Having no Intraretinal Fluid (IRF) and no Sub-retinal Fluid (SRF) in the Center Subfield at Weeks 36 and 64 | At Weeks 36 and 64 | Number of participants with no retinal fluid (no IRF and no SRF) in the central subfield at Weeks 36 and 64 |
| Secondary | Change From Baseline in Central Sub-field Thickness (CST) at Week 36 | From baseline to Week 36 | |
| Secondary | Change From Baseline in Central Sub-field Thickness (CST) at Week 64 | From baseline to Week 64 | |
| Secondary | Change From Baseline in NEI VFQ 25 Total Score at Week 36 | From baseline to Week 36 | NEI-VFQ-25: National Eye Institute Visual Functioning Questionnaire-25; The NEI VFQ-25 total score ranges from 0 to 100. A higher score means a better outcome (better patient-reported visual function). |
| Secondary | Change From Baseline in NEI VFQ 25 Total Score at Week 64 | From baseline at Week 64 | NEI-VFQ-25: National Eye Institute Visual Functioning Questionnaire-25; The NEI VFQ-25 total score ranges from 0 to 100. A higher score means a better outcome (better patient-reported visual function). |
| Secondary | Participants Dosed Only Q8 Through Week 36 in the 8 mg Q8 Group | Through Week 36 | Number of participants in the aflibercept 8q8/3 and the aflibercept 8q8/5 groups who were able to maintain every 8 weeks (Q8) dosing through Week 36. Only participants who did not discontinue study intervention prior to Week 36, and were therefore considered "completers" for Week 36, were included in the analysis of this endpoint. |
| Secondary | Participant Having Last Treatment Interval ≥12 or of 16 Weeks at Week 64 | At Week 64 | The proportion of participants having last completed treatment interval ≥12 or of 16 weeks at Week 64 for Week 64 completers. |
| Secondary | Participant Having Next Intended Interval ≥12, ≥16 or of 20 Weeks at Week 64 | At Week 64 | The proportion of participants having last intended treatment interval ≥12, ≥16 or 20 weeks at Week 64 for Week 64 completers. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Weeks 36 and 64 | Through Weeks 36 and 64 | TEAEs were defined as AEs that occurred in the time frame from first injection (active or sham) to the last injection (active or sham) plus 30 days. Ocular TEAEs in study eye and non-ocular TEAEs are included (ocular TEAEs in fellow eye are excluded) |
| Secondary | Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Weeks 36 and 64 | From baseline through Week 36 and 64 | Total aflibercept is the sum of free and adjusted bound aflibercept. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05850520/registered