Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
DrugSolution in Vial, intravitreal (IVT) injection
NCT Number: NCT04423718
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Phase 3
OFTALMOS, Instituto Oftalmologico de Alta Complejidad, Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Additional inclusion criteria for Year 3:
Exclusion criteria
Solution in Vial, intravitreal (IVT) injection
Solution in Vial, 2 mg, intravitreal (IVT) injection
Time frame: At baseline and Week 48
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
Time frame: At baseline and Week 60
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
Time frame: At Week 16
Time frame: At baseline and Week 48
Time frame: At Week 48
Time frame: At baseline and Week 48
Time frame: At baseline and Week 48
Time frame: At Week 48
Time frame: At baseline and Week 48
Time frame: At baseline and Week 48
NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)
Time frame: Up to Week 48
Time frame: Up to week 96
Bayer
Industry
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Acronym: PULSAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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