Proliferative Diabetic Retinopathy (PDR)Avenue-PDRNCT07923292
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
A study testing Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity in people with Proliferative Diabetic Retinopathy (PDR), run by Swansea Bay University Health Board at 1 site in United Kingdom.
Trial summary
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy (PDR)
- What is being tested?
- Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2026to Mar 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with diabetes
- Proliferative diabetic retinopathy
- Aged18 years or over
- New referrals
Who cannot join
- Follow up appointments i.e. treatment already started
- Eye complications which may make laser treatment difficult
- Vitreous haemorrhage
- Dense media opacity
- Eye care complications which prevent a view of the retina
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Swansea Bay University Health Board: Ophthalmology Department, Singleton Hospital
Swansea
Mahmoud Mr Awad, +44 1792 285034, mahmoud.awad@wales.nhs.uk
About this study
Official title: Assessing the Viability of Non-medical Practitioners Conducting Photocoagulation for PDR (AVENUE-PDR): A Feasibility Trial
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity.
To assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists in performing laser treatment in line with the established protocols.
- Conditions
- Proliferative Diabetic Retinopathy (PDR)
- Being tested
- Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacityOther
Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity
| Study group | Role | What they receive |
|---|---|---|
| Opthalmologist | Other | Not described Receives: Other: Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
| Trained non-medical professionals (eye care practitioners (ECPs) | Other | Not described Receives: Other: Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of a full clinical trial comparing trained Eye Care Professionals with ophthalmologists in performing laser treatment in line with the established protocols
Feasibility will be assessed using pre-specified progression criteria relating to:
ECP participation and training completion, participant recruitment, follow-up completion, intervention compliance and retention of clinical equipoise. We will use Red, Amber, Green criteria to determine whether a larger scale trial can be done
Measured: from enrollment to the 6 month follow up visit
Secondary outcomes (7)
estimate participant recruitment and retention rates.
to provide an estimate of the consent rates and retention rates by counting the number of patients screened and approached and how many consented. Of those, we will determine how many remained for the full 6 months and if patients withdrew or were lost to follow up we will determine when this occured and, where possible, why
Measured: from baseline to 6 month visit
assess completeness and quality of outcome data collection.
to assess how well data is collected and how accurate it is by conducting a data cleasning exercise in the database to identify which data are missing and any outliers suggesting data is inaccurate
Measured: from baseline to 6 month visit
evaluate the feasibility of intervention delivery by trained ECPs
to evalaute whether it is feasible for trained ECPs to deliver the treatment and whether patients accept them. this will include assessing (usign RAG criteria) whether ECPs agree to take part
Measured: from baseline to 6 month visit
assess the acceptability of the intervention and trial processes to participants and stakeholders.
to assess whether patients consent and remain in the trial and whether stakeholders can adhere to the protocol
Measured: from baseline to 6 month visit
describe clinical outcome distributions to inform the design of a future definitive trial
we will determine how will various clinical data items are collected in terms of availability and accuracy to determine whether they are suitable for a larger scale study which may use one as the basis for a sample size calculation. Data include number of laser sessions, visual acuity, central retinal thickness, sight loss/retention and various patient questionnaires
Measured: from baseline to 6 month visit
assess the feasibility of collecting patient-reported outcome and resource-use measures
to determine whether participants complete the questionnaires provided and which questions are missed out / incorrecty completed. We will run missing data reports on the questionnaires to track patterns relating to problematic questions and identify outliers which may be incorrect data
Measured: from baseline to 6 month visit
explore the resource use and cost drivers associated with ECP-delivered and ophthalmologist-delivered care pathways.
to collect data related to recourse use and other cost drivers associated with the novel treatment pathway using ECPs to determine whether there are cost savings to be made in using ECPs to deliver laser treatment
Measured: from baseline to 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic Retinopathy (PDR)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea Bay University Health Board
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923292
- Sponsor's protocol ID
- IRAS 347120
- Acronym
- Avenue-PDR
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Viability of Non-medical Practitioners Conducting Photocoagulation for PDR (AVENUE-PDR): A Feasibility Trial
- ClinicalTrials.gov ID
- NCT07923292
- Acronym / sponsor ID
- Avenue-PDR / IRAS 347120
- Conditions
- Proliferative Diabetic Retinopathy (PDR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Swansea Bay University Health BoardUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Nov 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.
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity.
To assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists in performing laser treatment in line with the established protocols.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opthalmologist | Other | Other: Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
| Trained non-medical professionals (eye care practitioners (ECPs) | Other | Other: Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People with diabetes
- Proliferative diabetic retinopathy
- Aged18 years or over
- New referrals
Key exclusion criteria (5 listed)
- Follow up appointments i.e. treatment already started
- Eye complications which may make laser treatment difficult
- Vitreous haemorrhage
- Dense media opacity
- Eye care complications which prevent a view of the retina
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 |
|---|---|---|
| Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacityTrained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity | Other | Opthalmologist, Trained non-medical professionals (eye care practitioners (ECPs) |
Primary outcome
To assess the feasibility of a full clinical trial comparing trained Eye Care Professionals with ophthalmologists in performing laser treatment in line with the established protocols
Time frame: from enrollment to the 6 month follow up visit
Feasibility will be assessed using pre-specified progression criteria relating to: ECP participation and training completion, participant recruitment, follow-up completion, intervention compliance and retention of clinical equipoise. We will use Red, Amber, Green criteria to determine whether a larger scale trial can be done
7 secondary outcomes
estimate participant recruitment and retention rates.
Time frame: from baseline to 6 month visit
assess completeness and quality of outcome data collection.
Time frame: from baseline to 6 month visit
evaluate the feasibility of intervention delivery by trained ECPs
Time frame: from baseline to 6 month visit
assess the acceptability of the intervention and trial processes to participants and stakeholders.
Time frame: from baseline to 6 month visit
describe clinical outcome distributions to inform the design of a future definitive trial
Time frame: from baseline to 6 month visit
assess the feasibility of collecting patient-reported outcome and resource-use measures
Time frame: from baseline to 6 month visit
explore the resource use and cost drivers associated with ECP-delivered and ophthalmologist-delivered care pathways.
Time frame: from baseline to 6 month visit
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 6 Nov 2026.
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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.
Swansea Bay University Health Board: Ophthalmology Department, Singleton Hospital
Swansea, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity in people with Proliferative Diabetic Retinopathy (PDR), run by Swansea Bay University Health Board at 1 site in United Kingdom.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of a full clinical trial comparing trained Eye Care Professionals with ophthalmologists in performing laser treatment in line with the established protocols (time frame: from enrollment to the 6 month follow up visit). 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 6 Nov 2026.