Type 2 Diabetes Trial, Recruiting NCT07458516 Sponsor: Association for Innovation and Biomedical Research on Light and Image Condition: Type 2 Diabetes
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Type 2 Diabetes Trial, Recruiting

NCT07458516
Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with Type 2 diabetes, based on 1985 World Health Organization standards.
  • People who are between 35 and 80 years old.
  • People whose vision (with glasses or contact lenses if needed) meets a minimum level of sharpness, equivalent to roughly 20/40 on a standard eye chart.
  • People whose glasses prescription falls within a certain range (spherical equivalent of less than 5 diopters).
  • People who have a specific stage of diabetic eye disease — either non-proliferative diabetic retinopathy at certain defined severity levels, or mild proliferative diabetic retinopathy meeting specific criteria — where the treating doctor and the patient agree that certain eye treatments can safely be delayed for at least 6 months.
  • People who are able to understand and sign a written consent form for the trial.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose retinal thickness in the central area of the eye exceeds a certain measurement (400 µm), unless specific conditions about fluid and retinal shape are met as assessed by the trial's reading centre (confirm with trial site).
  • People who show signs of scar tissue or abnormal blood vessel growth on the retina.
  • People who have poorly controlled pressure inside the eye, or a specific type of glaucoma caused by abnormal blood vessel growth.
  • People who show signs of abnormal blood vessel growth on the iris, or bleeding inside or in front of the retina.
  • People who have other blood vessel diseases affecting the eye, such as blockages in the retinal arteries or veins, or a wet form of age-related macular degeneration.
  • People who have previously had laser treatment across the retina (panretinal photocoagulation) or injections into the eye.
  • People who have had any eye surgery within the 6 months before joining the trial.
  • People whose vision inside the eye is significantly obscured by conditions such as a severe cataract, corneal scarring or swelling, or bleeding in the vitreous (the gel inside the eye).
  • People whose pupil does not dilate to at least 5 mm.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Inês P Marques, MD PhD, AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem

Phone: +351239480137

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Association for Innovation and Biomedical Research on Light and Image
Registry
ClinicalTrials.gov
Start date
24 November 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇵🇹 Portugal

Primary endpoints

Changes in capillary skeletonized vessel density (SVD); Changes in capillary perfusion density (PD) using OCTA; Foveal Avascular Zone (FAZ) area; Foveal Avascular Zone (FAZ) perimeter; Foveal Avascular Zone (FAZ) circularity; Changes in retinal ischemic area using UWF FFA; Changes in central retinal thickness (CRT); Changes in central intraretinal fluid; Changes in Disorganisation of Retinal Inner Layers (DRIL); Changes in Disorganisation of Retinal Outer Layers (DROL); Changes in Ganglion Cell Layer (GCL) + Inner Plexiform Layer (IPL) thickness; DRSS severity level; Changes in microaneurysm (...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov