Diabetes (DM)NCT07351786
Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy
An observational study of Diabetes (DM) and Retinopathy, Diabetic, run by Sara A Belal at 1 site in Egypt.
Trial summary
This study aims to test the impact of new-generation anti-diabetic drugs, such as SGLT2 inhibitors and DPP-4 inhibitors, on the development of diabetic retinopathy (DR). The study hypothesizes that these drugs have protective effects in diabetic retinopathy by delaying its incidence compared to older agents (including… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetes (DM), Retinopathy, Diabetic, Diabetic Retinopathy (DR)
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to Sep 2026
- Phase
- Observational
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited from Ophthalmology and Diabetes clinics from Alexandria University Main Hospitals.
Who may be able to join
- Diagnosed with Type 2 Diabetes for >5 years
- Using Diabetes medications (metformin, sulfonylureas, SGLT2 inhibitors, DPP-4 inhibitors) for a period of 2-3 years
Who cannot join
- Gestational Diabetes
- Type 1 Diabetes
- Severe non-proliferative diabetic retinopathy (NPDR) at baseline
- Proliferative diabetic retinopathy (PDR) at baseline
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University Main Hospitals - Diabetes clinics/ Ophthalmology clinics
Alexandria
About this study
This study aims to test the impact of new-generation anti-diabetic drugs, such as SGLT2 inhibitors and DPP-4 inhibitors, on the development of diabetic retinopathy (DR). The study hypothesizes that these drugs have protective effects in diabetic retinopathy by delaying its incidence compared to older agents (including metformin) only. Early intervention is critical, as treatment options for advanced stages of DR are limited in terms of their ability to restore impaired vision and their high associated costs. By focusing on delaying the occurrence of diabetic retinopathy, the investigators aim to reduce the burden of DR and improve the quality of life for diabetic patients.
Read the detailed description
This is a Cross-Sectional Study
- Conditions
- Diabetes (DM), Retinopathy, Diabetic, Diabetic Retinopathy (DR), Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Classical Oral Anti-Diabetic Drugs | Not described | |
| New-generation Oral Antidiabetic Drugs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of diabetic retinopathy, measured using Optos Ultra-widefield (UWF) Retinal Imaging, reported as ICDR (International Clinical Diabetic Retinopathy) score (0-4 scale).
Where 0 indicates no apparent diabetic retinopathy and 4 indicates proliferative diabetic retinopathy; higher scores indicate more severe (worse) diabetic retinopathy.
Measured: Assessed once per participant at baseline.
Secondary outcomes (3)
Glycemic control measured by HbA1c level using a standardized laboratory analyzer and reported in %.
Measured: Assessed once per participant at baseline.
Renal function measured by serum creatinine level using a standardized laboratory analyzer and reported in mg/dL.
Measured: Assessed once per participant at baseline.
Kidney damage status measured by UACR (Urine Albumin-to-Creatinine Ratio) using a standardized laboratory assay and reported as mg/g.
Measured: Assessed once per participant at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes (DM)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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara A Belal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara A Belal, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351786
- Sponsor's protocol ID
- 0108753
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Biochemical analysis and images could be shared (Anonymous)
Publications
Solomon SD, Chew E, Duh EJ, Sobrin L, Sun JK, VanderBeek BL, Wykoff CC, Gardner TW. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar;40(3):412-418. doi: 10.2337/dc16-2641. No abstract available.
PubMed 28223445O'Hara DV, Lam CSP, McMurray JJV, Yi TW, Hocking S, Dawson J, Raichand S, Januszewski AS, Jardine MJ. Applications of SGLT2 inhibitors beyond glycaemic control. Nat Rev Nephrol. 2024 Aug;20(8):513-529. doi: 10.1038/s41581-024-00836-y. Epub 2024 Apr 26.
PubMed 38671190Nentwich MM, Ulbig MW. Diabetic retinopathy - ocular complications of diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):489-99. doi: 10.4239/wjd.v6.i3.489.
PubMed 25897358Chawla A, Chawla R, Jaggi S. Microvasular and macrovascular complications in diabetes mellitus: Distinct or continuum? Indian J Endocrinol Metab. 2016 Jul-Aug;20(4):546-51. doi: 10.4103/2230-8210.183480.
PubMed 27366724
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT07351786
- Acronym / sponsor ID
- 0108753
- Conditions
- Diabetes (DM), Retinopathy, Diabetic, Diabetic Retinopathy (DR), Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sara A BelalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Jan 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.
This study aims to test the impact of new-generation anti-diabetic drugs, such as SGLT2 inhibitors and DPP-4 inhibitors, on the development of diabetic retinopathy (DR). The study hypothesizes that these drugs have protective effects in diabetic retinopathy by delaying its incidence compared to older agents (including metformin) only. Early intervention is critical, as treatment options for advanced stages of DR are limited in terms of their ability to restore impaired vision and their high associated costs. By focusing on delaying the occurrence of diabetic retinopathy, the investigators aim to reduce the burden of DR and improve the quality of life for diabetic patients.
Detailed description
This is a Cross-Sectional Study
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical Oral Anti-Diabetic Drugs | – | – |
| New-generation Oral Antidiabetic Drugs | – | – |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from Ophthalmology and Diabetes clinics from Alexandria University Main Hospitals.
Key inclusion criteria (2 listed)
- Diagnosed with Type 2 Diabetes for >5 years
- Using Diabetes medications (metformin, sulfonylureas, SGLT2 inhibitors, DPP-4 inhibitors) for a period of 2-3 years
Key exclusion criteria (5 listed)
- Gestational Diabetes
- Type 1 Diabetes
- Severe non-proliferative diabetic retinopathy (NPDR) at baseline
- Proliferative diabetic retinopathy (PDR) at baseline
- Pregnant and breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The level of diabetic retinopathy, measured using Optos Ultra-widefield (UWF) Retinal Imaging, reported as ICDR (International Clinical Diabetic Retinopathy) score (0-4 scale).
Time frame: Assessed once per participant at baseline.
Where 0 indicates no apparent diabetic retinopathy and 4 indicates proliferative diabetic retinopathy; higher scores indicate more severe (worse) diabetic retinopathy.
3 secondary outcomes
Glycemic control measured by HbA1c level using a standardized laboratory analyzer and reported in %.
Time frame: Assessed once per participant at baseline.
Renal function measured by serum creatinine level using a standardized laboratory analyzer and reported in mg/dL.
Time frame: Assessed once per participant at baseline.
Kidney damage status measured by UACR (Urine Albumin-to-Creatinine Ratio) using a standardized laboratory assay and reported as mg/g.
Time frame: Assessed once per participant at baseline.
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 20 Jan 2026.
- Background: PubMed 28223445Solomon SD, Chew E, Duh EJ, Sobrin L, Sun JK, VanderBeek BL, Wykoff CC, Gardner TW. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar;40(3):412-418. doi: 10.2337/dc16-2641. No abstract available.
- Background: PubMed 38671190O'Hara DV, Lam CSP, McMurray JJV, Yi TW, Hocking S, Dawson J, Raichand S, Januszewski AS, Jardine MJ. Applications of SGLT2 inhibitors beyond glycaemic control. Nat Rev Nephrol. 2024 Aug;20(8):513-529. doi: 10.1038/s41581-024-00836-y. Epub 2024 Apr 26.
- Background: PubMed 25897358Nentwich MM, Ulbig MW. Diabetic retinopathy - ocular complications of diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):489-99. doi: 10.4239/wjd.v6.i3.489.
- Background: PubMed 27366724Chawla A, Chawla R, Jaggi S. Microvasular and macrovascular complications in diabetes mellitus: Distinct or continuum? Indian J Endocrinol Metab. 2016 Jul-Aug;20(4):546-51. doi: 10.4103/2230-8210.183480.
- Individual participant dataSharing planned: Yes. Biochemical analysis and images could be shared (Anonymous)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes (DM) and Retinopathy, Diabetic, run by Sara A Belal at 1 site in Egypt.
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 2 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 20 Jan 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 Egypt. 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?
Contact Sara A Belal (+201554630615, phar-sara.belal@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of diabetic retinopathy, measured using Optos Ultra-widefield (UWF) Retinal Imaging, reported as ICDR (International Clinical Diabetic Retinopathy) score (0-4 scale). (time frame: Assessed once per participant at baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07351786, which also lists 4 linked publications.
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 20 Jan 2026.