Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anti-Vascular Endothelial Growth Factor.
- Who it may be relevant to
- Registry conditions: Diabetic Retinal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
Interventions
- Drug Anti-Vascular Endothelial Growth Factor
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the part
Primary outcome measures
- Change in multifocal pupillographic objective perimetry (mfPOP) response delays [Time frame: Baseline to 1 year]
- Change in area under the log contrast sensitivity function (AULCSF) [Time frame: Baseline to 1 year]
- Change in electroretinography parameter [Time frame: Baseline to 1 year]
- Change in reading performance [Time frame: Baseline to 1 year]
- Change in visual field function [Time frame: Baseline to 1 year]
- Change in diabetic retinopathy severity [Time frame: Baseline to 1 year]
- Change in retinal vascular pathology [Time frame: Baseline to 1 year]
- Change in retinal structure [Time frame: Baseline to 1 year]
- Change in retinal microvascular parameter [Time frame: Baseline to 1 year]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Diagnosed with Type 1 or Type 2 diabetes
- Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters)
- At least 1 eye with CI-DME requiring treatment
- Able and willing to provide informed consent.
Exclusion criteria
- Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina.
- Previous treatment of any kind for diabetic retinopathy or DME
- Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
- History of rhegmatogenous retinal detachment or macular hole
- History of vitrectomy
- Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07567833 · Protocol AS (1) · UG1EY014231