Diabetic Macular EdemaPhase 4VISION-AFNCT05511038
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
A Phase 4 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) in people with Diabetic Macular Edema, run by Bayer at 10 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesIndia
- Study dates
- 26 Aug 2022to 16 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male adult participant ≥18 years of age, with type 1 or 2 diabetes mellitus.
- Participant must have diabetic macular edema (DME) secondary to diabetes mellitus, involving the centre of the macula (defined as the area of the centre subfield of optical coherence tomography (OCT)) in the study eye.
- Decrease in vision, determined to be primarily the result of DME in the study eye.
- Retinal thickness of ≥300 µm in the study eye, as assessed by OCT.
- Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study ( ETDRS) letter score of 73 to 24 (i.e., VA of 20/50 to 20/320) or equivalent in the study eye.
- Participant for whom the decision to initiate treatment with Intravitreal (IVT) aflibercept has been made by the treating Investigator/Physician.
- Willing and able to comply with clinic visits and study-related procedures.
- Provide a signed Informed Consent Form (ICF) prior to any study procedures.
Who cannot join
- Having any contraindications to the use of IVT aflibercept as listed in the local prescribing information (i.e., ocular or periocular infection, active severe intraocular inflammation, and known hypersensitivity to aflibercept or to any of the excipients).
- History of vitreoretinal surgery and/or scleral buckling in the study eye.
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye.
- Received previous/ prior treatment as mentioned below:
- Received anti-Vascular Endothelial Growth Factor (VEGF) drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc., including aflibercept) within the last 3 months of Day 1.
- Received IVT dexamethasone or triamcinolone in the study eye within the last 3 months of Day 1.
Show all 14Show fewer
- Received intraocular or periocular corticosteroids in the study eye within the last 4 months of Day 1.
- Had fluocinolone implant in the study eye within the last 3 years of Day 1.
- Had dexamethasone implant in the study eye within the last 6 months of Day 1.
- systemic anti-angiogenic agents within 6 months of Day 1.
- Uncontrolled glaucoma in the study eye (patient who has had filtration surgery in the past, or likely to need filtration surgery in the future).
- Only 1 functional eye even if that eye is otherwise eligible for the study.
- Participated in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
- Pregnant or breast-feeding women.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
India10 sites
M & J Western Regional Institute of Ophthalmology
Ahmedabad, Gujarat, 380016
Raghudeep Eye Hospital
Ahmedabad, Gujarat, 380052
Narayana Nethralaya
Bengaluru, Karnataka, 560010
Sankara Eye Hospital
Bengaluru, Karnataka, 560037
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
Medical Research Foundation, Sankara Nethralaya
Chennai, Tamil Nadu, 600006
Lotus Eye Hospital and Institute
Coimbatore, Tamil Nadu, 641014
L.V. Prasad Eye Institute
Hyderabad, Andhra Pradesh, 500034
Disha Eye Hospitals
Kolkata, West Bengal, 700120
Dr. R.P. Centre for Ophthalmic Sciences, AIIMS
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: A Phase IV Interventional Post Approval Trial to Assess the Safety of Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema (DME) in Patients in India.
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.
Read more
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.
- Conditions
- Diabetic Macular Edema
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Drug
Injection, 2mg (equivalent to 50 µL solution for injection)
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Experimental | Participants will receive one aflibercept injection per month (every four weeks) for five consecutive doses, followed by one injection every alternate month (every 8 weeks) for rest of the duration Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency (Number) of Ocular and Non-ocular Treatment Emergent Adverse Events (TEAE).
Measured: An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
Secondary outcomes (4)
The Change in BCVA From Baseline to Week 52, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart or Equivalent.
Proportion of eyes that lose ≥ 5, 10 and 15 ETDRS letters from baseline to Week 52, Overall
Measured: From baseline to week 52
Change in Central Retinal Thickness (CRT) From Baseline to Week 52 as Measured by Optical Coherence Tomography (OCT), FA
Measured: From baseline to week 52
Proportion of Eyes That Gained ≥ 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters From Baseline to Week 52
Only 1 eye per patient was enrolled in the study. Therefore, number of participants equals to number of eyes.
Measured: From baseline to Week 52
Proportion of Eyes With a ≥2 Step Improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) Score
Only 1 eye per patient was enrolled in the study. Therefore, number of participants equals to number of eyes.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) is a standardized tool used to measure the severity of diabetic retinopathy. The scale assesses the level of retinal damage and provides a score based on the presence of specific lesions and the extent of retinal involvement.
Scale Range:
- Minimum score: 10 (indicating no retinopathy)
- Maximum score: 85 (indicating severe retinopathy)
Interpretation of Scores:
Higher scores indicate worse outcomes, reflecting more severe diabetic retinopathy
Measured: From baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start26 Aug 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511038
- Sponsor's protocol ID
- 21974
- Acronym
- VISION-AF
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2022
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Interventional Post Approval Trial to Assess the Safety of Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema (DME) in Patients in India.
- ClinicalTrials.gov ID
- NCT05511038
- Acronym / sponsor ID
- VISION-AF / 21974
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Experimental | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Participants will receive one aflibercept injection per month (every four weeks) for five consecutive doses, followed by one injection every alternate month (every 8 weeks) for rest of the duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female or male adult participant ≥18 years of age, with type 1 or 2 diabetes mellitus.
- Participant must have diabetic macular edema (DME) secondary to diabetes mellitus, involving the centre of the macula (defined as the area of the centre subfield of optical coherence tomography (OCT)) in the study eye.
- Decrease in vision, determined to be primarily the result of DME in the study eye.
- Retinal thickness of ≥300 µm in the study eye, as assessed by OCT.
- Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study ( ETDRS) letter score of 73 to 24 (i.e., VA of 20/50 to 20/320) or equivalent in the study eye.
Key exclusion criteria (14 listed)
- Having any contraindications to the use of IVT aflibercept as listed in the local prescribing information (i.e., ocular or periocular infection, active severe intraocular inflammation, and known hypersensitivity to aflibercept or to any of the excipients).
- History of vitreoretinal surgery and/or scleral buckling in the study eye.
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye.
- Received previous/ prior treatment as mentioned below:
- Uncontrolled glaucoma in the study eye (patient who has had filtration surgery in the past, or likely to need filtration surgery in the future).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Injection, 2mg (equivalent to 50 µL solution for injection) | Drug | Aflibercept |
Primary outcome
Frequency (Number) of Ocular and Non-ocular Treatment Emergent Adverse Events (TEAE).
Time frame: An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
4 secondary outcomes
The Change in BCVA From Baseline to Week 52, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart or Equivalent.
Time frame: From baseline to week 52
Change in Central Retinal Thickness (CRT) From Baseline to Week 52 as Measured by Optical Coherence Tomography (OCT), FA
Time frame: From baseline to week 52
Proportion of Eyes That Gained ≥ 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters From Baseline to Week 52
Time frame: From baseline to Week 52
Proportion of Eyes With a ≥2 Step Improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) Score
Time frame: From baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) in people with Diabetic Macular Edema, run by Bayer at 10 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency (Number) of Ocular and Non-ocular Treatment Emergent Adverse Events (TEAE). (time frame: An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.