Clinical Trials Logo

Clinical Trial Summary

The study will enroll up to 30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule. Only one eye of each subject will be enrolled in the study. All subjects will be enrolled at 1 site in the United States. Subjects must meet all inclusion and no exclusion criteria.


Clinical Trial Description

Description of Study Procedures and In-Office Visit: Enrollment/Screening: At the Enrollment/ Screening Visit, the exams will be conducted in the following order: 1. Patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures. 2. The following data will be collected for each study subject: 1. Subject's DOB 2. Gender 3. Number and type of injections and last injection date 3. The following data will be collected for the study eye: 1. Qualifying diagnosis for the study eye from the subject's medical record 2. From the subject's medical record, the presence of other ophthalmic conditions including but not limited to: i. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings, e.g., epi retinal membrane, macular hole, vitreo-macular traction (VMT) 4. Refraction correction 5. Snellen BCVA on both eyes on the day of the visit. 6. Selecting the study eye: 1. Both eyes of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device to get an acceptable single volume scan per eye. Scanning pattern to be used: Macular cube, 6X6mm, 128 B-scans per volume scan 2. The PI/CoPI will read the Zeiss Cirrus OCT scans of both eyes and will grade each eye for the presence/absence of SRF and/or IRF in the retina 3. The eye with SRF and/or IRF will be set as the study eye. In case both eyes were graded as fluid-present, the study eye will be set randomly 4. The Zeiss Cirrus OCT scan of the study eye will be part of the study analysis NOTE: Any planned treatment for NV-AMD should be administered after completion of all study-related scans OCT Scans: 1. The study eye of the subject will be scanned once, non-dilated, with a Zeiss Cirrus OCT device to get an acceptable single volume scan of the study eye in each repetition. Scanning pattern to be used: Macular cube, 6X6mm, 128 B-scans per volume scan 2. Following the Zeiss Cirrus OCT scans, the subject will be placed in a room with the Notal OCT V3.0 device which has been set up by a technician. 3. Notal OCT V3.0 scans 1. The technician will register the subject using the touchscreen of the Notal OCT V3.0 device and the assigned Subject ID. 2. On the first Notal OCT V3.0 device the subject will perform a self-tutorial. 3. The technician will set the first Notal OCT V3.0 for self-scan of the study eye. The subject will perform the tutorial on the eye with better vision, based on the subject's subjective decision, even if that eye is not the study eye. Then, the subject will perform on the first device- a calibration, and 5 volume scans. 4. The technician will set the second device for self-scans of the study eye. The subject will perform calibration and 5 volume scans. 5. The subject will be able to rest 1-2 minutes between self-scans 4. Collect AEs, if applicable. 5. Exit the subjects from the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05281042
Study type Observational
Source Notal Vision Inc.
Contact
Status Completed
Phase
Start date September 13, 2021
Completion date January 5, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04101877 - The Sahlgrenska Anti-VEGF Study Phase 2
Completed NCT03953079 - A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD Phase 2
Terminated NCT03577899 - Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1) Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Completed NCT01926977 - Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration Phase 1/Phase 2
Recruiting NCT00370539 - Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD Phase 3
Recruiting NCT03683251 - Extension Study for the Port Delivery System With Ranibizumab (Portal) Phase 3
Completed NCT03909425 - Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography
Completed NCT03744767 - Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration Phase 2
Recruiting NCT04690556 - Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD Phase 3
Completed NCT03677934 - A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration Phase 3
Recruiting NCT03594461 - Intense Treatment Regimen With Intravitreal Aflibercept Injection Phase 1/Phase 2
Completed NCT05131646 - Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Completed NCT04537884 - Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration Phase 1
Completed NCT03216538 - Safety and Efficacy of AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD) Phase 1/Phase 2
Completed NCT04304755 - Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD) Phase 2
Completed NCT01958918 - Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD Phase 4
Active, not recruiting NCT01918878 - Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration. Phase 4
Completed NCT01712035 - Neovascular Age-related Macular Degeneration
Recruiting NCT03021785 - A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration Phase 1