Recommendations for ISCEV-approved protocols for electroretinography in clinical trials

•1. Preamble

This document describes modules, protocols and sequences of modules for full-field (Ganzfeld) electroretinography (ERG) for the special application as a standardized test in clinical trials, in order to improve comparability between recordings from different sites, especially in multicenter trials. It provides globally harmonized recommendations that shall help to exploit the full power of electroretinography by providing a multitude of modules for specific functional targets (e.g. OFF-channel, S-cones etc.), whose function can be modified by specific compounds. The modules can be individually selected and -if properly combined- serve as backbone for a Standard Operating Procedure in a clinical trial that assesses retinal function by ERG.

ISCEV-approved protocols do not prevent any scientist responsible for a clinical trial from developing or extending his own ERG- protocol as a basis for a SOP to be applied in a certain study. If approval by ISCEV is desired, the modular structure and the open numbering of the modules provides for additional protocols for modules with specific purposes or applications to particular patient groups or expected drug actions. Specialists in clinical electroretinography are encouraged to complement the list of ISCEV-approved protocols as an ongoing process of further developing the application of electrophysiology in clinical trials on a globally harmonized scale.

To put it simply: ISCEV-approved protocols for individual modules are a series of "recipes" that can be selected freely. However, only if adopted by ISCEV t can and -if used- shall they be called "ISCEV-approved protocol No. xx"; ISCEV might add the name of a disease, a drug or a person for easier identification of a particular module/protocol.

•2. Purpose

•a. Modules

The purpose of an ISCEV Module is to specify parameters, settings of stimulation and recording as well as data evaluation procedures for certain purposes, patient populations or compounds in clinical trials, in order to complement the ISCEV standard by addition of modules that allow recording of particular retinal responses (such as OFF and S-Cone responses) or functional alterations ( e.g. by "submicrovolt recordings") that are not part of the standard itself. The list of modules (by Sept.1, 2008), examples of which are shown in fig.1, is as follows

() ISCEV Standard for clinical electroretinography (2008 update).* Marmor MF, Fulton A, Holder GE, Miyake Y (Chair), Brigell M, Bach M (for the International Society for Clinical Electrophysiology of Vision).