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THR-317-002: Clinical trial for the treatment of Diabetic Macular Oedema 10/05/2018

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Description

A randomized, single-masked, multicenter, phase II clinical trial to evaluate the safety and efficacy of a new treatment, THR-317 (8 mg), in combination with ranibizumab 0.5 mg, vs sham THR-317 injection and ranibizumab 0.5 mg, in patients with diabetic macular edema (DME).

Inclusion criteria

Patients with central DME without previous anti-VEGF treatment or with poor response to previous treatment with ranibizumab 0.5 mg. according to specific criteria.

Aim

To determine the safety and efficacy of THR-317 (8 mg) in combination with ranibizumab 0.5 mg as evaluated by best-corrected visual acuity change at month 3 as compared to baseline.

About the drug

THR-317 is an immunoglobulin G recombinant humanized monoclonal antibody directed against the Placental Growth Factor (PlGF) receptors types 1 and 2.

Who can participate

Patients with types 1 or 2 diabetes mellitus and DME with a visual acuity between 20/40 and 20/320, and without previous anti-VEGF treatment or with a poor response (as defined in the Protocol) to ranibizumab 0.5 mg. after a minimum of 3 intravitreal injections, the last one of which should have taken place 1 year previous to the screening visit as maximum. Further criteria apply.

Study duration

Approximately 5 months (140 days)

If you are interested in taking part in a clinical trial, please send us your personal details here and we will assess whether you are eligible.

 

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Injections intravitréennesRétinopathie diabétiqueŒdème maculaire diabétiqueOCT-angiographieTomographie par cohérence optiqueMicropérimétrieRétinographie
Last modified: 12 November, 2019 - 18:15