Non-Proliferative Diabetic RetinopathyPhase 3NCT06951087
Intravitreal and Intracameral DEX in NPDR
A Phase 3 study testing Dexamethasone sodium phosphate in people with Non-Proliferative Diabetic Retinopathy, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
To investigate the effects of intravitreal and intracameral injection of dexamethasone during cataract phacoemulsification in patients with mild to moderate non-proliferative diabetic retinopathy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Proliferative Diabetic Retinopathy
- What is being tested?
- Dexamethasone sodium phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2022to 1 Jun 2025
- Phase
- Phase 3
- 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
- type 2 diabetic cataracts patients who were diagnosed with mild to moderate NPDR
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Eye Institute, Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
About this study
Official title: Effect of Intravitreal and Intracameral Injection of Dexamethasone Sodium Phosphate on Mild to Moderate NPDR During Cataract Phacoemulsification
To investigate the effects of intravitreal and intracameral injection of dexamethasone during cataract phacoemulsification in patients with mild to moderate non-proliferative diabetic retinopathy
Read the detailed description
The study aims to analyze the impact of intravitreal and intracameral DEX in diabetic patients with NPDR who are undergoing phacoemulsification surgery. Specifically, the investigators will investigate its effects on postoperative macular central thickness, the development of DME, and the progression of DR.
- Conditions
- Non-Proliferative Diabetic Retinopathy
- Being tested
- Dexamethasone sodium phosphate
- Keywords
- non-proliferative diabetic retinopathy, cataract phacoemulsification, cystoid macular edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone sodium phosphateDrug
In patients with stable DR and no significant macular edema, intravitreal anti-VEGF injections after phacoemulsification surgery can prevent the worsening of postoperative macular edema and potentially improve final visual outcomes while maintaining safety. Laser coagulation and intravitreal anti-VEGF injections are currently considered the standard treatments for PDR. However, the cost of anti-VEGF drugs often prevents many patients from receiving regular and timely injections. Intravitreal corticosteroids may be used as an alternative to anti-VEGF agents.
| Study group | Role | What they receive |
|---|---|---|
| intravitreal DEX group | Experimental | Patients received an intravitreal injection of 0.5 mg DEX during phacoemulsification in the intravitreal DEX group Receives: Drug: Dexamethasone sodium phosphate |
| intracameral DEX group | Experimental | Patients received an intracameral injection of 0.5 mg DEX during phacoemulsification in the intracameral DEX group Receives: Drug: Dexamethasone sodium phosphate |
| the control group | No intervention | Patients received no injection during phacoemulsification in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the central point thickness (CPT) and central foveal thickness (CFT)
optical coherence tomography (OCT) was used to perform the retinal examination, macular cube scans (512 × 128) and measure the central point thickness (CPT) and central foveal thickness (CFT). The CPT measurement focused on a central circle with a diameter of 1mm, and the CFT was calculated as the average of three consecutive measurements
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start31 Jan 2022
- Primary completion20 Apr 2025
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951087
- Sponsor's protocol ID
- 2019-K068
- Other IDs
- 81974129, 82171038, 82101101
- Status last verified
- Dec 2024
- First submitted
- 7 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal and Intracameral Injection of Dexamethasone Sodium Phosphate on Mild to Moderate NPDR During Cataract Phacoemulsification
- ClinicalTrials.gov ID
- NCT06951087
- Acronym / sponsor ID
- 2019-K068
- Conditions
- Non-Proliferative Diabetic Retinopathy
- Keywords
- non-proliferative diabetic retinopathy, cataract phacoemulsification, cystoid macular edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 30 Apr 2025 (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 effects of intravitreal and intracameral injection of dexamethasone during cataract phacoemulsification in patients with mild to moderate non-proliferative diabetic retinopathy
Detailed description
The study aims to analyze the impact of intravitreal and intracameral DEX in diabetic patients with NPDR who are undergoing phacoemulsification surgery. Specifically, the investigators will investigate its effects on postoperative macular central thickness, the development of DME, and the progression of DR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intravitreal DEX group | Experimental | Drug: Dexamethasone sodium phosphatePatients received an intravitreal injection of 0.5 mg DEX during phacoemulsification in the intravitreal DEX group |
| intracameral DEX group | Experimental | Drug: Dexamethasone sodium phosphatePatients received an intracameral injection of 0.5 mg DEX during phacoemulsification in the intracameral DEX group |
| the control group | No intervention | –Patients received no injection during phacoemulsification in the control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetic cataracts patients who were diagnosed with mild to moderate NPDR
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Dexamethasone sodium phosphateIn patients with stable DR and no significant macular edema, intravitreal anti-VEGF injections after phacoemulsification surgery can prevent the worsening of postoperative macular edema and potentially improve final visual outcomes while maintaining safety. Laser coagulation and intravitreal anti-VEGF injections are currently considered the standard treatments for PDR. However, the cost of anti-VEGF drugs often prevents many patients from receiving regular and timely injections. Intravitreal corticosteroids may be used as an alternative to anti-VEGF agents. | Drug | intracameral DEX group, intravitreal DEX group |
Primary outcome
measure the central point thickness (CPT) and central foveal thickness (CFT)
Time frame: From enrollment to the end of treatment at 3 months
optical coherence tomography (OCT) was used to perform the retinal examination, macular cube scans (512 × 128) and measure the central point thickness (CPT) and central foveal thickness (CFT). The CPT measurement focused on a central circle with a diameter of 1mm, and the CFT was calculated as the average of three consecutive measurements
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 30 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone sodium phosphate in people with Non-Proliferative Diabetic Retinopathy, run by Affiliated Hospital of Nantong University at 1 site in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 2025. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
measure the central point thickness (CPT) and central foveal thickness (CFT) (time frame: From enrollment to the end of treatment at 3 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 30 Apr 2025.