First-in-Human Regulatory T Cell-Derived Exosomes Plus Ranibizumab for Refractory nAMD.

What was studied

This was an early safety trial of a new eye treatment. It involved people with neovascular age-related macular degeneration. Fluid stayed in their eyes despite repeated anti-VEGF injections. Doctors gave one injection of exosomes made from the person's own regulatory T cells. It was mixed with ranibizumab. The main aim was to check safety and find the top tolerated dose.

What they found

3 people got 0.05 mg and 1 person got 0.5 mg. The low-dose group had no dose-limiting harm or eye inflammation. Eye pressure stayed stable. Some low-dose people had better vision scores by day 90. The 0.5 mg person had sterile inflammation in the eye with vision loss. It cleared after local steroid treatment. The team stopped raising the dose. They set 0.05 mg as the top tolerated dose.

What it means for patients

The authors say 0.05 mg was tolerated. They say 0.5 mg was linked to dose-limiting harm. They say lower doses of this add-on treatment deserve more controlled study.

Why it is not certain yet

The 0.5 mg dose was given to only 1 person. It was a single-centre, open-label trial. The abstract calls the vision and eye scan results exploratory. An early safety trial cannot show how well a treatment works.

Source

First-in-Human Regulatory T Cell-Derived Exosomes Plus Ranibizumab for Refractory nAMD.

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