Trial · NCT06610747
Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT
NCT06610747, Not applicable, Recruiting, Zhongshan Ophthalmic Center, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT. Trials, record NCT06610747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06610747
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT
- NCT number
- NCT06610747
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 308 participants, estimated
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Conditions
- Diabetic Macular Edema
- Interventions
- Home-based Care Monitoring, Aflibercept 2Mg/0.05Ml Inj,Oph, Laser Treatment, Standard Hospital/clinic-based Care Monitoring
- First posted
- 2024-09-24
- Last updated
- 2026-06-08
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in best-corrected visual acuity (letter score) in the study eyes from the randomization visit to 96 week visit | From the randomization visit to 96 week visit | The randomization visit is defined as the visit of the 5th loading dose. Best-corrected visual acuity (letter score) will be measured by masked optometrists using the ETDRS tumbling-E eye chart. The testing procedures are detailed in the study protocol. |
| Secondary | Hospital/clinic visits with the home-based care group versus standard hospital/clinic-based care group | from the randomization visit to 96 week visit | Hospital/clinic visits for DME or DR is the principal secondary outcome. |
| Secondary | Proportion of study eyes with at least 5, 10 and 15 letter gains or losses in visual acuity | from the randomization visit to 96 week visit | Proportion of study eyes with at least 5, 10 and 15 letter gains or losses in visual acuity from the randomization visit to 96 week visit. Distribution of visual acuity outcomes (20/20 or better; 20/25 or better; 20/40 or better; 20/80 or better; 20/200 or better) will also be described. |
| Secondary | Change in OCT central subfield thickness | from the randomization visit to 96 week visit | OCT examinations will be conducted by masked, experienced technicians. The same machine type should be used throughout the study for each participant. The outcomes include change in OCT central subfield thickness and retinal volume. |
| Secondary | Change in OCT retinal volume | from the randomization visit to 96 week visit | OCT examinations will be conducted by masked, experienced technicians. The same machine type should be used throughout the study for each participant. The outcomes include change in OCT central subfield thickness and retinal volume. |
| Secondary | Long lapses in care | from the randomization visit to 96 week visit | Lapse in care will be defined as more than 2 weeks past the target date for a visit that is scheduled either 4 or 8 weeks after a completed visit or more than 4 weeks past the target date for a visit scheduled 16 or more weeks after a completed visit. Detailed definition is provided in the protocol. |
| Secondary | Ability to Work and Perform Regular Activities | from the randomization visit to 96 week visit | The Work Productivity and Activity Impairment Questionnaire Global Health (WPAI-GH, Simplified Chinese version) will be used to evaluate the ability to work and perform regular activities. The WPAI-GH is a validated survey tool that consists of 6 questions assessing the impact of health problems on work performance and on regular daily activities outside of work. |
| Other | Economic analysis (Cost-utility ratio) | from the randomization visit to 96 week visit | Costs and Utilities will be calculated over the duration of the trial. The incremental cost-utility ratio (ICUR) will be calculated by taking the incremental cost of the home-based care model over the hospital/clinic-based care model and dividing them by the incremental utilities of home-based care model over hospital/clinic-based care model. A probabilistic sensitivity analysis will be conducted to better characterize overall uncertainty in the results. Details are provided in the statistical analysis protocol (SAP). |
| Other | Change in best-corrected visual acuity (letter score) in the non-study eyes from the randomization visit to 96 week visit | From the randomization visit to 96 week visit | The randomization visit is defined as the visit of the 5th loading dose. Best-corrected visual acuity (letter score) will be measured by masked optometrists using the ETDRS tumbling-E eye chart. The testing procedures are detailed in the study protocol. Data in the non-study eyes will be analyzed. |
| Other | Change in best-corrected visual acuity (letter score) in the study eyes from the randomization visit to 48 week visit | From the randomization visit to 48 week visit | The randomization visit is defined as the visit of the 5th loading dose. Best-corrected visual acuity (letter score) will be measured by masked optometrists using the ETDRS tumbling-E eye chart. The testing procedures are detailed in the study protocol. Proportion of study eyes with at least 5, 10 and 15 letter gains or losses in visual acuity, distribution of visual acuity outcomes (20/20 or better; 20/25 or better; 20/40 or better; 20/80 or better; 20/200 or better) from the randomization visit to 48 week visit will also be described. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06610747
GET https://conductscience.org/api/trials/v1/NCT06610747/registered