check_circleStudy Completed
Diabetic macular edema
Bayer Identifier:
21974
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study to learn how safe the study drug intravitreal (given by an injection into the eye) aflibercept is in participants in India with diabetic macular edema
Trial purpose
Researchers are looking for a better way to treat people who have diabetic macular edema (DME).
Diabetic macular edema (DME) is a complication of diabetes. Consistently high blood sugar due to poor glucose control over time can damage small blood vessels in the body, including the eye. Damaged blood vessels in the eye may lead to leakage of the fluid into the central part of the retina at the back of the eye (also called macula) where sharp, straight-ahead vision occurs. Fluid accumulation makes the macula swell and results in reduced vision. If not treated, DME can result in complete loss of central detailed vision.
The study treatment intravitreal aflibercept (also called BAY865321) works by blocking VEGFR-1 receptor activity. Intravitreal aflibercept is already approved in over 105 countries for doctors to prescribe to people with DME. In India, aflibercept is approved conditionally for people with DME. The reason for this is that the sponsor was asked to collect more safety data for intravitreal aflibercept in Indian people with DME.
The main purpose of this study is to collect more data to learn how safe intravitreal aflibercept is in Indian people with DME. To see how safe intravitreal aflibercept is, the researchers will collect the information/data on the medical problems the participants may have during the study, and which may or may not be related to the study treatment. These medical problems are also known as “adverse events” (AEs). AEs will be categorized according to relatedness, seriousness, discontinuation of therapy, action taken and outcome.
The study participants will receive aflibercept as an injection directly into the space in the back of the eye once every 4 weeks in the first 5 months, followed by one injection every 8 weeks for the rest of the study duration. Only one eye per participant to be treated with aflibercept will be considered for the study.
Each participant will be in the study for approximately 52 weeks. The treatment duration will be 48 weeks. For each participant 11 visits to the study site are planned. The study team will perform additional safety calls 16 to 36 hours after each visit starting at visit 2. Alternatively, an additional safety visit can be arranged/planned for the day after treatment.
During the study, the study team will:
• take blood and urine samples
• examine the participants’ eyes
• do physical examinations
• examine heart health using ECG
• check vital signs
• ask the participants questions about how they are feeling and what adverse events they are having.
• in- administer the study drug
At the end of the study the participants will be switched to commercially available treatment if recommended by the study doctor/if the participant still benefits from the treatment.
Diabetic macular edema (DME) is a complication of diabetes. Consistently high blood sugar due to poor glucose control over time can damage small blood vessels in the body, including the eye. Damaged blood vessels in the eye may lead to leakage of the fluid into the central part of the retina at the back of the eye (also called macula) where sharp, straight-ahead vision occurs. Fluid accumulation makes the macula swell and results in reduced vision. If not treated, DME can result in complete loss of central detailed vision.
The study treatment intravitreal aflibercept (also called BAY865321) works by blocking VEGFR-1 receptor activity. Intravitreal aflibercept is already approved in over 105 countries for doctors to prescribe to people with DME. In India, aflibercept is approved conditionally for people with DME. The reason for this is that the sponsor was asked to collect more safety data for intravitreal aflibercept in Indian people with DME.
The main purpose of this study is to collect more data to learn how safe intravitreal aflibercept is in Indian people with DME. To see how safe intravitreal aflibercept is, the researchers will collect the information/data on the medical problems the participants may have during the study, and which may or may not be related to the study treatment. These medical problems are also known as “adverse events” (AEs). AEs will be categorized according to relatedness, seriousness, discontinuation of therapy, action taken and outcome.
The study participants will receive aflibercept as an injection directly into the space in the back of the eye once every 4 weeks in the first 5 months, followed by one injection every 8 weeks for the rest of the study duration. Only one eye per participant to be treated with aflibercept will be considered for the study.
Each participant will be in the study for approximately 52 weeks. The treatment duration will be 48 weeks. For each participant 11 visits to the study site are planned. The study team will perform additional safety calls 16 to 36 hours after each visit starting at visit 2. Alternatively, an additional safety visit can be arranged/planned for the day after treatment.
During the study, the study team will:
• take blood and urine samples
• examine the participants’ eyes
• do physical examinations
• examine heart health using ECG
• check vital signs
• ask the participants questions about how they are feeling and what adverse events they are having.
• in- administer the study drug
At the end of the study the participants will be switched to commercially available treatment if recommended by the study doctor/if the participant still benefits from the treatment.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
100Trial Dates
August 2022 - April 2024Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Raghudeep Eye Hospital | Ahmedabad, 380052, India |
Withdrawn | Raghudeep Eye Hospital | Ahmedabad, 380052, India |
Active, not recruiting | M & J Western Regional Institute of Ophthalmology | Ahmedabad, 380016, India |
Active, not recruiting | Lotus Eye Hospital and Institute | Coimbatore, 641014, India |
Active, not recruiting | Dr. R.P. Centre for Ophthalmic Sciences, AIIMS | New Delhi, 110029, India |
Active, not recruiting | Sankara Eye Hospital | Bengaluru, 560037, India |
Active, not recruiting | Narayana Nethralaya | Bengaluru, 560010, India |
Active, not recruiting | L.V. Prasad Eye Institute | Hyderabad, 500034, India |
Active, not recruiting | Disha Eye Hospitals | Kolkata, 700120, India |
Active, not recruiting | Post Graduate Institute of Medical Education and Research | Chandigarh, 160012, India |
Active, not recruiting | Medical Research Foundation, Sankara Nethralaya | Chennai, 600006, India |
Primary Outcome
- Number of ocular and non-ocular treatment-emergent adverse events (TEAEs)date_rangeTime Frame:At week 52
Secondary Outcome
- Change in best corrected visual acuity (BCVA)BCVA is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or equivalent.date_rangeTime Frame:From baseline to week 52
- Change in central retinal thickness (CRT)CRT is measured by optical coherence tomography (OCT), Fluorescein Angiography (FA).date_rangeTime Frame:From baseline to week 52
- Proportion of eyes that gain ≥ 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) lettersdate_rangeTime Frame:From baseline to week 52
- Proportion of eyes with a ≥2 step improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) scoredate_rangeTime Frame:From baseline to week 52
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1