Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion
brief summary
The goal of this clinical trial is to learn about the safety of the investigational medicinal product ANXV. It will also learn about how ANXV works to treat non-proliferative diabetic retinopathy and retinal vein occlusion in adults. The main questions it aims to answer are: * Is ANXV safe to use? * Does ANXV improve vision or findings related to vision decrease caused by non-proliferative diabetic retinopathy or retinal vein occlusion? * Does ANXV lower the number of times participants need to use a rescue medication? Researchers will compare different dose levels of ANXV to see what dose would be be appropriate to test in larger studies. Participants will: Take ANXV as a 30 minutes infusion (slow injection) for 5 days. Visit the clinic for checkups and tests at 11 visits during 4 months.
detailed description
The study is an open label, prospective, dose evaluation study to investigate the safety, tolerability and efficacy in patients with Non-Proliferative Diabetic Retinopathy (NPDR) or Retinal Rein Occlusion with recent onset (within 28 days from symptoms onset or diagnosis (whichever is first) to first treatment).
The study consists of 11 visits, whereof one screening visit, five treatment visits and five follow up visits, during a 4 months period.
Intervention is intravenous infusion (30 minutes) with the investigational medicinal product ANXV, a recombinant Annexin A5 protein. The intended dose levels are 4 mg, 1 mg and 6 mg, daily administration for five days.
Safety will be regularly evaluated by the Medical Monitors on a per need basis, as data become available. In case of safety concerns within one indication subset (NPDR and RVO), a lower dose will be initiated within the concerned indication subset (for each subset, independently).
The following assessments will be performed:
Ocular assessments:
* BCVA * OCT and OCTA * ERG * UWF-retinal imaging * UWF-FFA * Ocular examination - Slit Lamp biomicroscopy examination, Intraocular Pressure (IOP), RAPD * Dilated indirect ophthalmoscopy
Non-ocular assessments:
* Vital signs * ECG * Safety labs (blood and urine) * Study labs (blood)
official title
Open-label, Safety, Tolerability and Proof of Concept Study to Evaluate the Use of ANXV (Recombinant Human Annexin A5 Protein) in the Treatment of Patients With Either Diabetic Retinopathy or Recent Onset Retinal Vein Occlusion