NCT04241198

Brief Summary

The study will include up to 30 AMD patients, recruited by two medical centers, Tel-Aviv medical center and Assuta Hashalom medical center. At the screening visit, the patients will be imaged in their tested, eligible eye(s), using a commercial Zeiss Cirrus or Heidelberg Spectralis OCT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 9, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

June 15, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

January 22, 2020

Last Update Submit

June 14, 2023

Conditions

A. AMD Patients, Where at Least One Eye is With Active CNV, Presenting Retinal Fluid at the Enrolment Visit, Undergoing Active Anti-VEGF Treatment

Outcome Measures

Primary Outcomes (1)

  • To describe the dynamics of retinal fluid

    To describe the dynamics of retinal fluid in eyes undergoing anti-VEGF therapy as manifested in self-operated OCT in daily home testing

    30 days

Secondary Outcomes (2)

  • To evaluate patient experience when self-operating the Notal-OCT V3.0.

    30 days

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

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AMD patients, where at least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment

You may qualify if:

  • Ability and willingness to give informed consent (IC)
  • years of age or older at the time of IC
  • Tested eye(s) diagnosed with AMD
  • Visual acuity of 20/400 Snellen (6/120) or better in the study eye
  • At least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment
  • Ability to undergo OCT testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TLV Medical Center

Tel Aviv, Israel

Location

Study Officials

  • michaela Glodstein, Dr

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

June 9, 2020

Primary Completion

July 30, 2022

Study Completion

March 28, 2023

Last Updated

June 15, 2023

Record last verified: 2023-04

Locations

IL(1)