Diabetic Macular EdemaADHERENCT07567898
Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates
A study testing multidisciplinary protocolized intervention (MPI) and Routine medical care & monitoring in people with Diabetic Macular Edema and Neovascular (Wet) Age-Related Macular Degeneration, run by Singapore Eye Research Institute.
Trial summary
The purpose of this research study is to test whether a personalised care approach improves adherence compared to standard care. Many patients with macular diseases like age-related macular degeneration and diabetic macular edema need regular eye injections to protect their vision. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema, Neovascular (Wet) Age-Related Macular Degeneration, Intravitreal Injection
- What is being tested?
- multidisciplinary protocolized intervention (MPI) and Routine medical care & monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with chronic macula disease including those diagnosed with nAMD and DME, who require IVT.
- This would include treatment naive patients (no IVT in either eye the last 6 months) and previously treated patients who have had IVT in either eye in the last 6 months and require further IVT treatment at the baseline study visit in either eye.
- Able to provide informed consent and must consent to undergoing the MPI intervention.
- Speak English or Mandarin.
- Must be a Singapore resident.
Who cannot join
- Patients who are unwilling or unable to perform CAT testing.
- Unable to provide informed consent.
- Significant eye pathology such as cornea problems, glaucoma, or other retinal diseases that may substantially affect vision.
- Do not speak English or Mandarin fluently.
- Cognitive impairment (as assessed using 6CIT).
- Obvious observable physical or hearing disabilities that prevents them from completing the CAT questionnaire and undergoing MPI effectively.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of Multidisciplinary Protocolised Interventions to Reduce Non-adherencE Rates (ADHERE) in Patients With Chronic Macula Diseases Receiving Intravitreal Injections: A Randomised Controlled Trial
The purpose of this research study is to test whether a personalised care approach improves adherence compared to standard care. Many patients with macular diseases like age-related macular degeneration and diabetic macular edema need regular eye injections to protect their vision. However, some do not adhere to their treatment appointments, risking further vision loss.
You were selected as a possible participant in this research study because you have been diagnosed with neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) requiring intravitreal injection treatment (IVT).
Read more
This research study targets to recruit 200 participants from the Singapore National Eye Centre.
This study comprises two cohort groups: Cohort 1(Suboptimal CAT scores/ Randomized Control trial) and Cohort 2 (Optimal CAT scores/Observation).
If you agree to take part in this study, the research coordinator will obtain your written consent before proceeding with the study procedures. You will be required to complete CAT assessment (via remote or administered in clinic) and assigned to cohort 1 or cohort 2 based on CAT scores result. If you are assigned to cohort 1, you will be randomly allocated to either the personalized multi-disciplinary protocolized intervention (MPI) or standard care group. Randomization means assigning you to one of two groups by chance, like tossing a coin or rolling a dice.
- MPI group: You will complete a specialized computerized adaptive testing (CAT) quality of life questionnaire. Based on the domain specific scores, you will receive a medical consultation and a referral to nurse educators, optometrists, occupational therapists, or social workers.
- Standard care group: If you are allocated to this group, you will receive standard care, where doctors make treatment decisions without using the CAT results.
If you are assigned to cohort 2, you will be placed under prospective observation and undergo routine clinical care.
- Conditions
- Diabetic Macular Edema, Neovascular (Wet) Age-Related Macular Degeneration, Intravitreal Injection
- Being tested
- multidisciplinary protocolized intervention (MPI), Routine medical care & monitoring
- Keywords
- ADHERE, Macular diseases, Intravitreal injections., neovascular age-related macular
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary protocolized intervention (MPI)Behavioural
Our novel proposed approach to improve adherence to IVT is personalized patient-centred care comprising a multidisciplinary protocolized intervention (MPI), which consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW).
Routine medical care & monitoringBehavioural
The CAT scores will be recorded by the clinical research coordinator at baseline and follow-up visits for comparison to the MPI arm.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary protocolized intervention (MPI) | Active comparator | Consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW).
CATs specific to AMD and DME will be used to measure QoL by collecting scores in various patient-informed domains. Lower scores at baseline, or a significant reduction in scores on follow-up visits in the various domains, will inform potential areas to address and tailor our MPI accordingly. Receives: Behavioral: multidisciplinary protocolized intervention (MPI) |
| Standard care | Placebo comparator | In the standard care arm, the treating clinician will be masked from the CAT scores and will use his/her own discretion when recommending the treatment regimen or when making any appropriate nurse or allied health referrals, independent of the CAT scores. Receives: Behavioral: Routine medical care & monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of multidisciplinary protocolized intervention (MPI) in improving adherence to intravitreal (IVT) Injection.
Adherence is defined as
- patient attends all follow-up appointments within 1 month of the planned follow up date, and
- patient receives IVT within 1 month of when the doctor recommends IVT. At each follow up time point, the study team will assess if the patient has been "adherent" or "non-adherent". If the patient does not visit the clinic or does not attend the scheduled study visit, phone calls will be made to determine reasons or barriers for adherence. A remote invitation to complete the CAT questionnaire will also be sent to these patients or if uncontactable, they will be approached and interviewed at their next clinical visit. For previously treated patients, adherence status up to 2 years prior to study enrolment for the time of IVT treatment will be recorded by the study team from medical records.
Measured: From 6 month to 18 months.
Secondary outcomes (5)
Comparison of CAT scores (Specific aim 2A) from the CAT questionnaire database
CAT scores will be collected via a hybrid remote or in-clinic delivery method. At baseline, CATs will be administered in-clinic or via CAT links sent by WhatsApp to their contact number . At subsequent timepoints, relevant CAT links will be sent via a WhatsApp message to their designated contact number, to complete the questionnaire remotely on their own SMART device, before their appointment.
Those who are unable to complete CAT testing remotely will be given an additional opportunity to complete them in-clinic using an internet enabled tablet in person at their clinic visit with/without CRC assistance. The CAT scores will be assessed by clinical research coordinator.
Measured: Baseline, 6,12 and 18 month
Effectiveness of MPI in improvement of visual function
Visual function -Monocular and binocular presenting corrected VA and CS (Specific aim 2B) will be collected from the clinical records. If data are not present, the CRCs will conduct these tests on participants using standardized protocols.domain-specific CAT scores at each follow-up time point. Compared to those in standard care, patients in the MPI group will have improved VA and CS at each follow-up time point.
Measured: Enrolment to 18 months
Effectiveness of MPI in increasing disease-free intervals in patients with nAMD or DME receiving IVT and having suboptimal CAT scores.
Disease free intervals as defined by the maximum IVT treatment interval where no disease activity recurrence is detected on OCT will be collected from clinical records and OCT images from the clinical database (Specific aim 2B).
Measured: At the end of 18-month time point.
The implementation outcomes of MPI through mixed method testing with interviews and questionnaires (Specific aim 3).
The PI, assisted by their Co-Is and collaborators, will identify eligible individuals for qualitative interviewing that will be performed with major stakeholders between 6 to 15 months timeline. These include the clinicians, nurses and the allied health specialists (OP, OT and SW) who will be involved in administering the MPI, and patients and care-givers who receive the MPI. Potential individuals will be contacted over email or phone call, and a trained study team will follow up on affirmative responses by obtaining written informed consent to carry out the following study procedures.
Semi-structured (1-on-1) interviews with the above key stakeholders will be conducted to explore their perspectives on barriers and enablers of integrating MPI into a Singapore public hospital for the management of nAMD and DME patients receiving IVT. Purposive and snowball sampling will be used to ensure all stakeholder groups are represented. Interviews will be conducted until no new data emerges.
Measured: 6 to 15 months.
To assess the cost-effectiveness of the MPI for improving adherence to IVT, considering its potential impact on long term visual acuity (VA) loss and QoL adjusted years (QALYs).
The sample size required for cost-effectiveness analysis is usually larger than clinical studies as it involves estimating the joint distribution of patient outcomes and costs. Furthermore, power calculations require setting a willingness-to-pay threshold, which is not known for Singapore. However, as cost-effectiveness is more concerned with estimating effect size rather than hypothesis testing, it can still provide valuable information even if underpowered. Instead of confidence intervals, sensitivity analysis will be used to assess the range of estimated values.
Measured: Baseline and 18-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study comprises two arms- Multidisciplinary protocolized intervention (MPI) versus Standard care arm. Intervention for MPI arm with sub-optimal CAT scores consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore National Eye Centre
- Responsible party
- Principal investigator, Tan Cheng Sim Anna, Singapore Eye Research Institute
- Investigators
- Anna CS Tan, PhD, Principal investigator, Singapore Eye Research Institute (SERI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567898
- Sponsor's protocol ID
- MOH-001922-00
- Acronym
- ADHERE
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Multidisciplinary Protocolised Interventions to Reduce Non-adherencE Rates (ADHERE) in Patients With Chronic Macula Diseases Receiving Intravitreal Injections: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07567898
- Acronym / sponsor ID
- ADHERE / MOH-001922-00
- Conditions
- Diabetic Macular Edema, Neovascular (Wet) Age-Related Macular Degeneration, Intravitreal Injection
- Keywords
- ADHERE, Macular diseases, Intravitreal injections., neovascular age-related macular
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Collaborators
- Singapore National Eye Centre
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test whether a personalised care approach improves adherence compared to standard care. Many patients with macular diseases like age-related macular degeneration and diabetic macular edema need regular eye injections to protect their vision. However, some do not adhere to their treatment appointments, risking further vision loss.
You were selected as a possible participant in this research study because you have been diagnosed with neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) requiring intravitreal injection treatment (IVT).
This research study targets to recruit 200 participants from the Singapore National Eye Centre.
This study comprises two cohort groups: Cohort 1(Suboptimal CAT scores/ Randomized Control trial) and Cohort 2 (Optimal CAT scores/Observation).
If you agree to take part in this study, the research coordinator will obtain your written consent before proceeding with the study procedures. You will be required to complete CAT assessment (via remote or administered in clinic) and assigned to cohort 1 or cohort 2 based on CAT scores result. If you are assigned to cohort 1, you will be randomly allocated to either the personalized multi-disciplinary protocolized intervention (MPI) or standard care group. Randomization means assigning you to one of two groups by chance, like tossing a coin or rolling a dice.
- MPI group: You will complete a specialized computerized adaptive testing (CAT) quality of life questionnaire. Based on the domain specific scores, you will receive a medical consultation and a referral to nurse educators, optometrists, occupational therapists, or social workers.
- Standard care group: If you are allocated to this group, you will receive standard care, where doctors make treatment decisions without using the CAT results.
If you are assigned to cohort 2, you will be placed under prospective observation and undergo routine clinical care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study comprises two arms- Multidisciplinary protocolized intervention (MPI) versus Standard care arm. Intervention for MPI arm with sub-optimal CAT scores consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW).
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary protocolized intervention (MPI) | Active comparator | Behavioral: multidisciplinary protocolized intervention (MPI)Consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW). CATs specific to AMD and DME will be used to measure QoL by collecting scores in various patient-informed domains. Lower scores at baseline, or a significant reduction in scores on follow-up visits in the various domains, will inform potential areas to address and tailor our MPI accordingly. |
| Standard care | Placebo comparator | Behavioral: Routine medical care & monitoringIn the standard care arm, the treating clinician will be masked from the CAT scores and will use his/her own discretion when recommending the treatment regimen or when making any appropriate nurse or allied health referrals, independent of the CAT scores. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic macula disease including those diagnosed with nAMD and DME, who require IVT.
- This would include treatment naive patients (no IVT in either eye the last 6 months) and previously treated patients who have had IVT in either eye in the last 6 months and require further IVT treatment at the baseline study visit in either eye.
- Able to provide informed consent and must consent to undergoing the MPI intervention.
- Speak English or Mandarin.
- Must be a Singapore resident.
Key exclusion criteria (6 listed)
- Patients who are unwilling or unable to perform CAT testing.
- Unable to provide informed consent.
- Significant eye pathology such as cornea problems, glaucoma, or other retinal diseases that may substantially affect vision.
- Do not speak English or Mandarin fluently.
- Cognitive impairment (as assessed using 6CIT).
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 |
|---|---|---|
| multidisciplinary protocolized intervention (MPI)Our novel proposed approach to improve adherence to IVT is personalized patient-centred care comprising a multidisciplinary protocolized intervention (MPI), which consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW). | Behavioural | Multidisciplinary protocolized intervention (MPI) |
| Routine medical care & monitoringThe CAT scores will be recorded by the clinical research coordinator at baseline and follow-up visits for comparison to the MPI arm. | Behavioural | Standard care |
Primary outcome
Effectiveness of multidisciplinary protocolized intervention (MPI) in improving adherence to intravitreal (IVT) Injection.
Time frame: From 6 month to 18 months.
Adherence is defined as 1. patient attends all follow-up appointments within 1 month of the planned follow up date, and 2. patient receives IVT within 1 month of when the doctor recommends IVT. At each follow up time point, the study team will assess if the patient has been "adherent" or "non-adherent". If the patient does not visit the clinic or does not attend the scheduled study visit, phone calls will be made to determine reasons or barriers for adherence. A remote invitation to complete the CAT questionnaire will also be sent to these patients or if uncontactable, they will be approached and interviewed at their next clinical visit. For previously treated patients, adherence status up to 2 years prior to study enrolment for the time of IVT treatment will be recorded by the study team from medical records.
5 secondary outcomes
Comparison of CAT scores (Specific aim 2A) from the CAT questionnaire database
Time frame: Baseline, 6,12 and 18 month
Effectiveness of MPI in improvement of visual function
Time frame: Enrolment to 18 months
Effectiveness of MPI in increasing disease-free intervals in patients with nAMD or DME receiving IVT and having suboptimal CAT scores.
Time frame: At the end of 18-month time point.
The implementation outcomes of MPI through mixed method testing with interviews and questionnaires (Specific aim 3).
Time frame: 6 to 15 months.
To assess the cost-effectiveness of the MPI for improving adherence to IVT, considering its potential impact on long term visual acuity (VA) loss and QoL adjusted years (QALYs).
Time frame: Baseline and 18-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingPhase 2/3
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RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
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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.
Anna CS Tan, PhD principal investigator
Singapore Eye Research Institute (SERI)
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary protocolized intervention (MPI) and Routine medical care & monitoring in people with Diabetic Macular Edema and Neovascular (Wet) Age-Related Macular Degeneration, run by Singapore Eye Research Institute.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Tan CS Clinical Associate Professor, PhD (+65-63227424, anna.tan.c.s@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of multidisciplinary protocolized intervention (MPI) in improving adherence to intravitreal (IVT) Injection. (time frame: From 6 month to 18 months.). 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 5 May 2026.