NCT04078672

Brief Summary

The study will include up to 250 AMD patients and up to 30 DR patients. In Tel Aviv medical center up to 100 AMD/ 20 DR patients will be recruited; In Assuta HaShalom up to 100 AMD/10 DR patients will be recruited; In Bnei Zion medical center up to 50 AMD patients will be recruited. 4.1 Study population 1. AMD patients - intermediate and advanced AMD (with active or non-active CNV) 2. DR patients - with and without edema 4.2 Inclusion criteria

  1. 1.Ability and agreement to give informed consent (IC)
  2. 2.Diagnosis of AMD or DR in SE by OCT
  3. 3.Ability to undergo OCT scans
  4. 4.VA of 20/400 (6/120) or better in study eye(s)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2023

Completed
Last Updated

June 15, 2023

Status Verified

April 1, 2023

Enrollment Period

3.2 years

First QC Date

August 27, 2019

Last Update Submit

June 14, 2023

Conditions

AMDDR

Outcome Measures

Primary Outcomes (1)

  • To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT

    The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.

    Less then an hour

Secondary Outcomes (3)

  • To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and a by commercial OCT

    Less then an hour

  • To evaluate repeatability

    Less then an hour

  • To evaluate the level of agreement between NOTAL-OCT V3.0 and a commercial OCT in the presence of fluid

    Less then an hour

Study Arms (1)

AMD

EXPERIMENTAL

NOTAL-OCT V3.0 scan

Procedure: NOTAL-OCT V3.0

Interventions

NOTAL-OCT V3.0PROCEDURE

AMD and DR patients

Also known as: OCT scan
AMD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Ability and agreement to give informed consent (IC) 2. Diagnosis of AMD or DR in SE by OCT 3. Ability to undergo OCT scans 4. VA of 20/400 (6/120) or better in study eye(s)

You may not qualify if:

  • \. Patient with dilated eye(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assuta Hashalom

Tel Aviv, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2019

First Posted

September 6, 2019

Study Start

December 2, 2019

Primary Completion

January 30, 2023

Study Completion

March 26, 2023

Last Updated

June 15, 2023

Record last verified: 2023-04

Locations

IL(2)