Visit Day. Day of actual receipt of the Museum’s services.
Visit Day. 1 Perform the following assessments: • Query for AEs • Xxxxx xxxxx (Blood Pressure, Pulse Rate) • BCVA (ETDRS) • Slit-lamp exam and biomicroscopy • IOP • Indirect ophthalmoscopy • SD-OCT • Collect Blood Specimen for RBM-007 plasma level • Upload all collected images to Sponsor or representative. • Schedule the subject to return for the Visit Day 7 (±1).
Visit Day. 28 (Day 28±2) The following assessments must be performed, prior to optional administration of anti- VEGF medication at investigator discretion: • Query for AEs • Xxxxx xxxxx (Blood Pressure, Pulse Rate) • BCVA (ETDRS) • Slit-lamp exam and biomicroscopy • IOP • Indirect ophthalmoscopy • SD-OCT • Fundus photography • Fluorescein angiography • OCT-angiography • Collect blood specimen for RBM-007 plasma level • Order and review the following tests to be performed at local laboratory: • hematology and serum chemistry. • At completion of the study visit, the clinical Investigator may resume intravitreal anti- VEGF injection at their clinical discretion, using ranibizumab, aflibercept or bevacizumab at their choice. • Any anti-VEGF treatment should be performed only after completing all evaluations and procedures for the study visit • Upload all collected images to Sponsor or representative. • Schedule the subject to return for Visit Day 56 (±3).
Visit Day. 56 (±3) Perform the following assessments: • Query for AEs • Physical exam • Xxxxx xxxxx (Blood Pressure, Pulse Rate) • BCVA (ETDRS) • Slit-lamp exam and biomicroscopy • IOP • Indirect ophthalmoscopy • SD-OCT • Fundus photography • Fluorescein angiography • OCT angiography • At completion of the study visit, the clinical Investigator may administer intravitreal anti-VEGF injection at their clinical discretion, using ranibizumab, aflibercept or bevacizumab at their choice. • Any anti-VEGF treatment is performed only after completing all other evaluations and procedures for the study visit • Upload all collected images to Sponsor or representative. • Exit subject from study.
Visit Day. 7 (Day 7±1) Perform the following assessments: • Query for AEs • Xxxxx xxxxx (Blood Pressure, Pulse Rate) • BCVA (ETDRS) • Slit-lamp exam and biomicroscopy • IOP • Indirect ophthalmoscopy • SD-OCT • Collect blood specimen for RBM-007 plasma levels • Review Rescue Criteria for anti-VEGF intravitreal injection in study eye • Rescue Criteria: • Vision loss in study eye from Baseline Visit of more than 10 ETDRS letters • Increase from Baseline Visit of more than 100 µm in the central subfield on SD- OCT • Clinical investigator assessment that rescue with standard therapy is indicated IF RESCUE CRITERIA ARE MET, proceed with intravitreal injection of anti-VEGF in study eye. Clinical Investigator may select which intravitreal anti-VEGF injection to use at their clinical discretion, using ranibizumab, aflibercept or bevacizumab at their choice. • Any anti-VEGF injection should be performed only after all evaluations and procedures for the study visit are completed. • Upload all collected images to Sponsor or representative. • Schedule the subject to return for Visit 28 (Day 28±2)．
Visit Day. The date of the visit of service engineers to the site shall be as per mutual agreement of both the parties during normal working days and hours. After receiving the emergency call on any day, the will attend the problem within 2 hours in urban areas & 4 hours in rural areas as depending upon the distance and situation. FORCE MAJEURE: Offer is subject to usual force majeure clause.
