A Study to Investigate RO7200220 in Diabetic Macular Edema
Diabetic Macular Edema
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diabetes mellitus (Type 1 or Type 2)
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
- Decreased visual acuity attributable primarily to DME
- Ability and willingness to provide written informed consent and to comply with the study protocol
- Willingness to allow Aqueous Humor collection
- For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of <1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment
Exclusion Criteria:
- Hemoglobin A1c (HbA1c) of greater than (>) 12%
- Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Prior treatment with panretinal photocoagulation or macular laser to the study eye
- Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
- Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
- Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
- Prior administration of IVT brolucizumab (Beovu®): ever; RO7200220: </=24 weeks prior to Day 1) in either eye
- Any proliferative diabetic retinopathy
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
- Other protocol-specified inclusion/exclusion criteria may apply
Sites / Locations
- Win RetinaRecruiting
- Retina-Vitreous Associates Medical GroupRecruiting
- Retina Consultants, San DiegoRecruiting
- Retinal Consultants Med GroupRecruiting
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterRecruiting
- Bay Area Retina AssociatesRecruiting
- Colorado Retina Associates, PCRecruiting
- Emerson Clinical Research Institute LLCRecruiting
- Rand EyeRecruiting
- Pinnacle Research Institute
- National Ophthalmic Research InstituteRecruiting
- Retina Macula Specialists of Miami - LeJeune Road Office
- Florida Retina InstituteRecruiting
- Retina Vitreous Associates of FloridaRecruiting
- Retina Specialists of TampaRecruiting
- Butchertown Clinical TrialsRecruiting
- Cumberland Valley Retina ConsultantsRecruiting
- Tallman Eye AssociatesRecruiting
- Deep Blue Retina PLLCRecruiting
- Sierra Eye AssociatesRecruiting
- Opthalmic Consultants of LIRecruiting
- Buffalo Niagara Retina Associates
- Retina Associates of Western New YorkRecruiting
- Western Carolina Retinal Associate PARecruiting
- Wake Forest University Health SciencesRecruiting
- Meridian Clinical ResearchRecruiting
- Cleveland Clinic FoundationRecruiting
- Verum Research LLCRecruiting
- EyeHealth NorthwestRecruiting
- Erie Retinal SurgeryRecruiting
- Eye Care Specialists, PCRecruiting
- Sewickley Eye GroupRecruiting
- Charleston Neuroscience InstituteRecruiting
- Black Hills Eye InstituteRecruiting
- Retina Consultants of NashvilleRecruiting
- Texas Retina AssociatesRecruiting
- Austin Clinical Research LLCRecruiting
- Valley Retina Institute P.A.Recruiting
- Medical Center Ophthalmology AssociatesRecruiting
- Retina Consultants of TexasRecruiting
- Strategic Clinical Research Group, LLCRecruiting
- Piedmont Eye CenterRecruiting
- Wagner Kapoor InstituteRecruiting
- Centro Oftalmológico Dr. Charles S.A.
- Oftalmos
- Buenos Aires MáculaRecruiting
- Centro Privado de Ojos RomagosaRecruiting
- Centro de ojos Loria
- OftarRecruiting
- Microcirugía Ocular S.ARecruiting
- Grupo Laser VisionRecruiting
- Organizacion Medica de InvestigacionRecruiting
- The Retina Centre of Ottawa
- Toronto Retina Institute
- Institut De L'Oeil Des Laurentides
- Faculty Hospital Ostrava; Ophthalmology clinic
- Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
- General Teaching Hospital Prague; Ophthalmology clinic
- AXON Clinical
- Pusan National University HospitalRecruiting
- Yeungnam University Medical CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Kim's Eye HospitalRecruiting
- Centrum Medyczne Julianow
- Dobry Wzrok Sp Z O O
- Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
- Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
- Centrum Medyczne UNO-MED
- SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego
- Centrum Diagnostyki i Mikrochirurgii Oka LENS
- LensClinicRecruiting
- Caminomed
- Emanuelli Research and Development Center LLCRecruiting
- Hospital General de Catalunya; Servicio de oftalmologia
- Hospital Universitario Puerta de Hierro; Servicio de oftalmologia
- Oftalvist Valencia
- Hospital Universitario Miguel Servet; Servicio de Oftalmologia
- Bradford Royal InfirmaryRecruiting
- Bristol Eye HospitalRecruiting
- Gloucestershire Hospitals NHS Foundation TrustRecruiting
- Royal Surrey County Hospital
- Moorfields Eye Hospital NHS Foundation TrustRecruiting
- Royal Victoria InfirmaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Arm A: 0.25 mg RO7200220 Q8W
Arm B: 1.0 mg RO7200220 Q8W
Arm C: 1.0 mg RO7200220 Q4W
Arm D: 0.5 mg Ranibizumab Q4W
Participants will receive RO7200220 0.25 milligrams (mg), by Intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections.
Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.