Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591598
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
A Study to Learn About the Blood Levels of Aflibercept When High-dose Aflibercept is Injected in Both Eyes of Participants With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Non-randomized Multi-center Phase 4 Pharmacokinetic Study to Evaluate the Systemic Exposure After Bilateral Intravitreal Administration of High Dose 8 mg Aflibercept in Adults With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEUTERON
Brief Summary:
Researchers are looking for a better way to treat participants who have diabetic macular edema DME or neovascular age-related macular degeneration nAMD
DME is a diabetes-related eye disorder In DME the macula swells up due to fluid leakage from damaged blood vessels resulting in vision problems DME is a leading cause of vision loss in working age adults nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula the central part of the retina nAMD is a leading cause of vision loss for people aged 50 and older
The study treatment Aflibercept also called BAY 86-5321 is a drug that blocks a protein called vascular endothelial growth factor VEGF which causes abnormal growth and leakage of blood vessels at the back of the eye
The main purpose of this study is to to collect more information on the blood levels of aflibercept when 8 mg aflibercept is injected in both eyes of participants with DME or nAMD
For this the researchers will analyze Maximum observed concentration Cmax the highest amount of aflibercept in participants blood will be measured after multiple doses of aflibercept during the study
Participants will receive 8 mg aflibercept as injections into the vitreous cavity jelly-like substance that fills the centre of the eye of both eyes
Participants will be divided into three groups and will receive initial and maintenance injections of 8 mg aflibercept in both eyes Researchers will closely monitor the health of the participants during the study
During the study the doctors and their study team will
take blood and urine samples
do physical examinations
examine heart health using electrocardiogram ECG
check vital signs such as blood pressure heart rate body temperature
ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study Doctors keep track of all adverse events irrespective if they think it is related or not to the study treatments
DME is a diabetes-related eye disorder In DME the macula swells up due to fluid leakage from damaged blood vessels resulting in vision problems DME is a leading cause of vision loss in working age adults nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula the central part of the retina nAMD is a leading cause of vision loss for people aged 50 and older
The study treatment Aflibercept also called BAY 86-5321 is a drug that blocks a protein called vascular endothelial growth factor VEGF which causes abnormal growth and leakage of blood vessels at the back of the eye
The main purpose of this study is to to collect more information on the blood levels of aflibercept when 8 mg aflibercept is injected in both eyes of participants with DME or nAMD
For this the researchers will analyze Maximum observed concentration Cmax the highest amount of aflibercept in participants blood will be measured after multiple doses of aflibercept during the study
Participants will receive 8 mg aflibercept as injections into the vitreous cavity jelly-like substance that fills the centre of the eye of both eyes
Participants will be divided into three groups and will receive initial and maintenance injections of 8 mg aflibercept in both eyes Researchers will closely monitor the health of the participants during the study
During the study the doctors and their study team will
take blood and urine samples
do physical examinations
examine heart health using electrocardiogram ECG
check vital signs such as blood pressure heart rate body temperature
ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study Doctors keep track of all adverse events irrespective if they think it is related or not to the study treatments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None