Clinical trial OAKS-DERBY: efficacy and safety of APL-2 in the treatment of geographic atrophy secondary to AMD 14/02/2020
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This is a multicentre, randomised, double masked phase III clinical trial, controlled by simulated treatment. It compares the efficacy and safety of intravitreal APL-2 treatment with simulated injections in patients with geographic atrophy secondary to age-related macular degeneration.
Main inclusion criteria
Patients of 60 and above who present geographic atrophy secondary to age-related macular degeneration and who have not received any previous treatment in the study eye.
The size of the lesion should be between 2.5 and 17.5mm².
There must be hyper-autofluorescence and vision must be equal to or greater than 24 letters (approximate Snellen equivalent of 20/320).
The main aim will be to assess the efficacy of APL-2 compared to simulated injection in patients with geographic atrophy secondary to age-related macular degeneration, determined according to the change in lesion size at 12 months according to autofluorescence.
About the drug
The biochemical, genetic and clinical lines of evidence in humans indicate that the complement system plays a role in the etiology of age-related macular degeneration.
Complement protein C3 (which has a pro-inflammatory action), the membrane attack complex and complement factor H are present in drusen and in basal laminar deposits of patients with age-related macular degeneration.
APL-2 is a drug for intravitreal use that blocks the action of C3, its main action being anti-inflammatory.
The results of previous studies support the start of the phase III trial to assess the efficacy and safety of APL-2 in order to reduce the progression of geographic atrophy.
The duration of this trial is two and a half years (30 months).
* Institut Registration Code: E08607500. Clinica trial n. EudraCT 2018-001436-22 (study 303) and 2018-001435-52 (study 304). Clinical trial authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS) and the CEIm of the Quironsalud Hospital Group in Barcelona.
IF YOU WANT TO PARTICIPATE IN A CLINICAL TRIAL, SEND US YOUR DATA HERE AND WE EVALUATE IF YOU ARE ELEGIBLE