Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422507
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-15
Brief Title:
A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Multi-Center Randomized Double-Masked Active-Controlled Phase 3 Study of the Efficacy and Safety of 8 mg Aflibercept in Chinese Participants With Diabetic Macular Edema
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHOTONiC
Brief Summary:
Researchers are looking for a better way to treat people who have diabetic macular edema
Diabetic macular edema DME is a diabetes-related eye disorder In DME the macula which is the central part of the retina at the back of the eye swells up resulting in vision problems This happens due to leakage of fluid from damaged blood vessels
The study treatment 8 milligram mg aflibercept is injected into the eye It works by blocking a protein called vascular endothelial growth factor VEGF which causes abnormal growth and leakage of blood vessels at the back of the eye
A lower dose of aflibercept 2 mg is already approved for the treatment of DME Based on the findings of another study the higher dose of aflibercept 8 mg is expected to reduce the frequency of injections required for treating DME while being equally safe and working as well as the lower dose The higher dose could make it easier to treat DME and improve quality of life for people with DME
The main purpose of this study is to learn if high-dose 8 mg aflibercept given every 16 weeks works as well as low-dose 2 mg aflibercept given every 8 weeks in Chinese participants
For this the researchers will compare the change in participants best corrected visual acuity BCVA after 48 weeks of starting the treatment BCVA is the clearest vision a participant can have with the help of corrective lenses such as glasses It will be measured by the number of letters the participant can read on an eye chart This is known as their Early Treatment Diabetic Retinopathy Study ETDRS letter score
Participants will be randomly by chance assigned to one of two treatment groups to receive study treatment as an injection into the eye up to Week 56
2 mg aflibercept every 8 weeks after receiving 5 initial monthly doses
8 mg aflibercept every 16 weeks after receiving 3 initial monthly doses
Each participant will be in the study for around 63 weeks with up to 18 visits to the study site This includes
one visit up to 21 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
16 visits during which the treatment will be given Most of these visits will have a gap of 4 weeks except for one visit that will happen a few days after the previous visit
one visit 4 weeks after the treatment ends
During the study the doctors and their study team will
check the participants vision and their overall eye health using different eye tests
check participants health by performing tests such as blood and urine tests
ask the participants questions about the disease and study treatment and how these impact their quality of life
ask the participants 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 of whether they think they are related to the study treatment
Access to study treatment after the end of this study is not planned Participants can switch to available approved treatments for DME
Diabetic macular edema DME is a diabetes-related eye disorder In DME the macula which is the central part of the retina at the back of the eye swells up resulting in vision problems This happens due to leakage of fluid from damaged blood vessels
The study treatment 8 milligram mg aflibercept is injected into the eye It works by blocking a protein called vascular endothelial growth factor VEGF which causes abnormal growth and leakage of blood vessels at the back of the eye
A lower dose of aflibercept 2 mg is already approved for the treatment of DME Based on the findings of another study the higher dose of aflibercept 8 mg is expected to reduce the frequency of injections required for treating DME while being equally safe and working as well as the lower dose The higher dose could make it easier to treat DME and improve quality of life for people with DME
The main purpose of this study is to learn if high-dose 8 mg aflibercept given every 16 weeks works as well as low-dose 2 mg aflibercept given every 8 weeks in Chinese participants
For this the researchers will compare the change in participants best corrected visual acuity BCVA after 48 weeks of starting the treatment BCVA is the clearest vision a participant can have with the help of corrective lenses such as glasses It will be measured by the number of letters the participant can read on an eye chart This is known as their Early Treatment Diabetic Retinopathy Study ETDRS letter score
Participants will be randomly by chance assigned to one of two treatment groups to receive study treatment as an injection into the eye up to Week 56
2 mg aflibercept every 8 weeks after receiving 5 initial monthly doses
8 mg aflibercept every 16 weeks after receiving 3 initial monthly doses
Each participant will be in the study for around 63 weeks with up to 18 visits to the study site This includes
one visit up to 21 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
16 visits during which the treatment will be given Most of these visits will have a gap of 4 weeks except for one visit that will happen a few days after the previous visit
one visit 4 weeks after the treatment ends
During the study the doctors and their study team will
check the participants vision and their overall eye health using different eye tests
check participants health by performing tests such as blood and urine tests
ask the participants questions about the disease and study treatment and how these impact their quality of life
ask the participants 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 of whether they think they are related to the study treatment
Access to study treatment after the end of this study is not planned Participants can switch to available approved treatments for DME
Detailed Description:
EYLEA aflibercept 40 mgmL solution for injection at a dosage level of 2 mg administered intravitreally IVT is approved in over 100 countries for the treatment of DME Despite the proven efficacy and safety of EYLEA in patients with DME there remains an unmet need for alternative therapies that can decrease the burden of DME treatment via a reduction in the required frequency of IVT injections while improving visual and anatomic outcomes The overall one and two year results of PHOTON a global phase 23 trial evaluating high dose HD or 8 mg aflibercept in participants with center-involved diabetic macular edema DME demonstrate the benefit of HD aflibercept for reducing the frequency of injections required for the treatment of DME while providing visual and anatomic outcomes non-inferior to and a safety profile indistinguishable from EYLEA 2 mg aflibercept the established standard of care for the treatment of DME The observed reduction in the number of HD aflibercept injections required for the treatment of DME over 2 years in PHOTON is expected to translate into the benefit of reducing the burden of treatment and thereby improving the quality of life for DME patients their caregivers and health care providers This study aims to investigate the efficacy and safety of HD aflibercept in Chinese participants with DME over 60 weeks with the primary objective of achieving non-inferior best corrected visual acuity BCVA with an extended dosing interval every 16 weeks after 3 initial monthly injections vs 2 mg aflibercept every 8 weeks after 5 initial monthly injections similar to the results obtained in PHOTON This study is designed to support the registration of HD aflibercept for the treatment of DME in China
Primary Objective The primary objective of the study is to determine if treatment with HD aflibercept at intervals of 16 weeks provides non-inferior best-corrected visual acuity BCVA compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants
Secondary Objectives
To determine the effect of HD aflibercept vs 2 mg aflibercept on anatomic and other visual measures of response
To evaluate the safety immunogenicity and pharmacokinetics PK of HD aflibercept in Chinese participants
Primary endpoint
Change from baseline in BCVA by ETDRS letter score at Week 48
Secondary endpoints
Change from baseline in BCVA by ETDRS letter score at Week 60
Participants gaining 15 letters at Week 48 and Week 60
Participants achieving an ETDRS letter score of at least 69 approximate 2040 Snellen equivalent at Week 48
Participants with no IRF andor no SRF in the center subfield at Week 48
Change from baseline in central subfield thickness CST at Week 48
Change from baseline in leakage on fluorescein angiography FA at Week 48
Change from baseline in National Eye Institute Visual Function Questionnaire NEI-VFQ total score at Week 48
Occurrence of treatment-emergent adverse events TEAEs and serious adverse events SAEs through Weeks 48 and 60
Participants developing a treatment-emergent ADA response or Nabs to aflibercept through EOS at Week 60
Systemic exposure to aflibercept as assessed by plasma concentrations of free adjusted bound and total aflibercept from baseline through Week 48 This study is a phase 3 multi-center randomized double-masked active-controlled study in Chinese participants with DME involving the center of the macula to investigate the efficacy and safety of HD aflibercept versus 2 mg aflibercept
The primary objective of the study is to determine if treatment with HD aflibercept at 16 week intervals provides non-inferior BCVA compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants
322 eligible participants randomized in a 11 ratio to the following 2 treatment groups
1 2q8 2 mg aflibercept every 8 weeks following 5 initial monthly doses n161 and
2 HDq16 HD aflibercept every 16 weeks following 3 initial monthly doses n161 The study consists of a screening period a treatment period and an end of study EOS visit at Week 60 The study duration for a participant is approximately 63 weeks The EOS is defined as the last visit of the last participant No study treatment will be administered at the EOS visit at Week 60
HD aflibercept is the sponsors study intervention under investigation The following intervention groups are included in the study
2 mg aflibercept every 8 weeks 2q8
8 mg aflibercept every 16 weeks HDq16
Primary Objective The primary objective of the study is to determine if treatment with HD aflibercept at intervals of 16 weeks provides non-inferior best-corrected visual acuity BCVA compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants
Secondary Objectives
To determine the effect of HD aflibercept vs 2 mg aflibercept on anatomic and other visual measures of response
To evaluate the safety immunogenicity and pharmacokinetics PK of HD aflibercept in Chinese participants
Primary endpoint
Change from baseline in BCVA by ETDRS letter score at Week 48
Secondary endpoints
Change from baseline in BCVA by ETDRS letter score at Week 60
Participants gaining 15 letters at Week 48 and Week 60
Participants achieving an ETDRS letter score of at least 69 approximate 2040 Snellen equivalent at Week 48
Participants with no IRF andor no SRF in the center subfield at Week 48
Change from baseline in central subfield thickness CST at Week 48
Change from baseline in leakage on fluorescein angiography FA at Week 48
Change from baseline in National Eye Institute Visual Function Questionnaire NEI-VFQ total score at Week 48
Occurrence of treatment-emergent adverse events TEAEs and serious adverse events SAEs through Weeks 48 and 60
Participants developing a treatment-emergent ADA response or Nabs to aflibercept through EOS at Week 60
Systemic exposure to aflibercept as assessed by plasma concentrations of free adjusted bound and total aflibercept from baseline through Week 48 This study is a phase 3 multi-center randomized double-masked active-controlled study in Chinese participants with DME involving the center of the macula to investigate the efficacy and safety of HD aflibercept versus 2 mg aflibercept
The primary objective of the study is to determine if treatment with HD aflibercept at 16 week intervals provides non-inferior BCVA compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants
322 eligible participants randomized in a 11 ratio to the following 2 treatment groups
1 2q8 2 mg aflibercept every 8 weeks following 5 initial monthly doses n161 and
2 HDq16 HD aflibercept every 16 weeks following 3 initial monthly doses n161 The study consists of a screening period a treatment period and an end of study EOS visit at Week 60 The study duration for a participant is approximately 63 weeks The EOS is defined as the last visit of the last participant No study treatment will be administered at the EOS visit at Week 60
HD aflibercept is the sponsors study intervention under investigation The following intervention groups are included in the study
2 mg aflibercept every 8 weeks 2q8
8 mg aflibercept every 16 weeks HDq16
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None