A First in Human trial to study safety and tolerability of single rising intravitreal doses (oPen label, non-randomized, uncontrolled) and in Addition the early biological Response of mulTiple intravitreal doses (double-masked, RandomIzed, shamcontrolleD) of BI 765128 in panretinal photocoaGulation (PRP) treated diabetic rEtinopathy (DR) patients with diabetic macular ischemia (DMI) - the PARTRIDGE Study
- Conditions
- Diabetic Macular IschemiaDMI10047061
- Registration Number
- NL-OMON53613
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
Part B:
• Panretinal photocoagulation-treated DR patients with either no or inactive
retinal neovascularization per investigator judgement
• Presence of significant DMI: Large foveal avascular zone (FAZ) defined as
those with >=0.5mm2 area present on OCTA. If FAZ is <0.5mm2 then an enlarged
peri-foveal inter-capillary space in at least 1 quadrant will be sufficient.
• Best-corrected VA <=85 letters (20/20) in the study eye
Part B:
• Diabetic Macular Edema (DME), defined as a CST >= 305µm for men and >= 290 µm
for women (Optovue Angiovue) in the study eye
• Subjects receiving IVT injections for active DME (anti-VEGF, steroids) and
macular laser in the previous 3 months to screening in the study eye
• History of vitrectomy in the study eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A:<br /><br>- Number of subjects with ocular dose limiting events (DLEs) from drug<br /><br>administration until day 8 (7 days after treatment)<br /><br>Part B:<br /><br>- Number of subjects with drug-related AEs from drug administration until EOS</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A:<br /><br>- Number of subjects with drug related AEs at EOS<br /><br>- Number of subjects with any ocular AEs (eye disorders) at EOS<br /><br>Part B:<br /><br>- Change from baseline of the size of the FAZ in optical coherence tomography<br /><br>angiography (OCTA) at visit 5<br /><br>- Change from baseline of the size of the FAZ in optical coherence tomography<br /><br>angiography (OCTA) at visit 6<br /><br>- Change from baseline of the size of the FAZ in optical coherence tomography<br /><br>angiography (OCTA) at visit 7<br /><br>- Change from baseline of BCVA at Visit 7<br /><br>- Number of subjects with any ocular AEs (eye disorders) from drug<br /><br>administration until EOS</p><br>