" En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials (OCTAPS)
Primary Purpose
Maculopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
spectral domain optical coherence tomography
multifocal electroretinogram
Sponsored by
About this trial
This is an interventional screening trial for Maculopathy focused on measuring Toxicity, Drug
Eligibility Criteria
Inclusion Criteria:
- Patients treated with synthetic antimalarials with retinal damage (in relation with the antimalarial treatment) recently diagnosed by mfERG
- Patients treated with synthetic antimalarials in the past, who stopped treatment because of a supposed retinal damage not confirmed by mfERG
Exclusion Criteria:
- State of ocular structures preventing the realization of exams
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
"En face" OCT (C-scan)
Arm Description
Outcomes
Primary Outcome Measures
concordance between mfERG and "En-face" OCT
measure of kappa coefficient
Secondary Outcome Measures
Full Information
NCT ID
NCT02805686
First Posted
June 15, 2016
Last Updated
January 24, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02805686
Brief Title
" En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials
Acronym
OCTAPS
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The maculopathy induced by the retinal toxicity of the synthetic antimalarials must be detected at the infra-clinical state, when it can still be reversible. Identifying early retinal anatomical changes has always represented (a challenge for medical interns, dermatologists, rheumatologists, and ophthalmologists). Currently, the gold-standard for its screening and its diagnostic is the multifocal electroretinogram (mfERG), however it is a long and tedious exam, offered by only few medical centers. It is recommended to find a simple non-invasive alternative, on a commonly used equipment. The study of the ellipsoid (junction line between, the external and internal photoreceptor segments) using optical coherence tomography (OCT-SD) "en face" enables us, to obtain a panoramic viewing of the state of the photoreceptor layer, and to detect any modification, even subtle, within this layer. The OCT-SD "en face" can be easily done by any ophthalmologist who owns one.
The proportion of "en face" OCT-SD showing suggestive retinal damage and patients who present retinal damage in relation with synthetic antimalarial treatments and diagnosed by mfERG is considered in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maculopathy
Keywords
Toxicity, Drug
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"En face" OCT (C-scan)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
spectral domain optical coherence tomography
Intervention Type
Device
Intervention Name(s)
multifocal electroretinogram
Primary Outcome Measure Information:
Title
concordance between mfERG and "En-face" OCT
Description
measure of kappa coefficient
Time Frame
after 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients treated with synthetic antimalarials with retinal damage (in relation with the antimalarial treatment) recently diagnosed by mfERG
Patients treated with synthetic antimalarials in the past, who stopped treatment because of a supposed retinal damage not confirmed by mfERG
Exclusion Criteria:
- State of ocular structures preventing the realization of exams
12. IPD Sharing Statement
Learn more about this trial
" En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials
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