This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. The study comprises two subparts, 1 (PK/PD) and 2 (proof of concept); both subparts will be conducted in parallel. To…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Outcome Measures:
• DRSS improvement >=2 steps at 48 Weeks of treatment in the study eye
DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.
Secondary outcome
Secondary Outcome Measures:
• Vision threatening complications at 48 weeks of treatment in the study eye
• DRSS improvement >=2 steps at 24 Weeks of treatment in the study eye
• Frequency of treatment emergent adverse events
Background summary
Proof-of-concept study to investigate the efficacy and safety of runcaciguat
(BAY 1101042) in patients with moderately severe to severe non-proliferative
diabetic retinopathy.
Study objective
This Phase 2 study is conducted to investigate the safety and efficacy of
runcaciguat in the treatment of diabetic retinopathy. The study comprises two
subparts, 1 (PK/PD) and 2 (proof of concept); both subparts will be conducted
in parallel. To assess the efficacy, the retinal morphology will be
investigated by 7-field color fundus photography (CFP) supported by 7 Field FA
images for the assessment of the DRSS by a central reading center. Two-step
DRSS improvement at 48 weeks of treatment will be the primary efficacy
endpoint. DRSS assessment will continue until the end of the 48-week treatment
period. In addition, vision-threatening complications will be recorded
throughout the study and assessed as secondary efficacy endpoint.
Study design
Multicenter, randomized, double-masked, parallel-group, placebo-controlled
study.
Intervention
Runcaciguat is being compared to placebo.
Study burden and risks
More information on the safety as well as burden and risks is available in the
PIIC and the IB.
In addition there could be potential side effects or potential burden due to
the procedures done in this study.
If the burden and risks are perceived as disadvantageous for the patient, the
patient can always stop the study without giving any reason and without
experiencing any consequences for medical care.
Siriusdreef 36
Hoofddorp 2132 WT
NL
Siriusdreef 36
Hoofddorp 2132 WT
NL
Listed location countries
Age
Inclusion criteria
- Moderately severe to severe NPDR in the study eye: DRSS levels 47 or 53
- Diabetes type 1 or 2
- BCVA ETDRS letter score in the study eye of >=69 letters (approximate Snellen
equivalent of 20/40 or better)
Exclusion criteria
- Presence or history of macular edema involving the center of the macula
(defined as the area of the center subfield on OCT) in the study eye with
visual impairment or in need of treatment with anti-VEGF, immediately or
anticipated within the next 3 months, by judgement of the investigator or with
OCT central subfield thickness above gender specific thresholds, measured
including Bruch*s membrane, >=305 µm in women, >= 320 µm in men, as provided by
the central reading center
- Any kind of neovascular growth in the study eye, including anterior segment
neovascularization
- Arterial hypotension with systolic blood pressure < 100 or diastolic blood
pressure < 60mmHg
- ALT or AST above 3 x ULN or bilirubin >= 1.5 ULN at screening, known ascites
- Estimated glomerular filtration rate (eGFR CKD-EPI) below 30 ml/min/1.73 m2
at screening
- Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the
study eye
- Any prior intraocular steroid injection in the study eye
- Any prior grid or focal laser photocoagulation within 500 microns of the
foveal center or any prior PRP in the study eye
- Use of nitrates or NO donors (such as amyl nitrate) in any form including
topical; PDE5 inhibitors, non-specific PDE inhibitors within 1 week before
first study drug administration
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002333-15-NL |
| CCMO | NL75162.056.21 |