The Institut de la Màcula sees in 2020 with a new clinical trial for geographic atrophy secondary to AMD14/02/2020 · News
The Institut de la Màcula has begun the OAKS-DERBY clinical trial for the treatment of geographic atrophy secondary to AMD. Currently, it is in the process of selecting the candidates who, free of charge, will access a state-of-the-art drug and an innovative treatment
The Institut de la Màcula has seen in 2020 by starting a new clinical trial, OAKS-DERBY*, with a new generation and long-lasting drug indicated for geographic atrophy secondary to age-related macular degeneration (AMD). This is a multicentre, randomised, double masked phase III clinical trial, controlled by simulated treatment.
The principal aim is to assess the efficacy of APL-2 in comparison with simulated injections in patients with geographic atrophy secondary to AMD, determined according to the change in lesion size at 12 months according to autofluorescence.
The trial, which will last two and a half years (30 months), is now in the candidate selection process. The trials only admit a limited number of patients and are subject to rigorous inclusion criteria:
- Patients aged over 60 who present geographic atrophy secondary to AMD
- Those 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).
Participation in this clinical trial enables free access to innovative treatment, with personalised and cutting-edge care by expert ophthalmologists. It is also the only way of accessing a new drug that is not yet available to the general public but has already shown very good results in previous studies.
The biochemical, genetic and clinical lines of evidence in humans indicate that the complement system plays a role in the etiology of AMD. 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 AMD.
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 a phase III trial to assess the efficacy and safety of APL-2 in order to reduce the progression of geographic atrophy.
Those interested in participating can send their details using the form below and our team of professionals will then call them to assess their eligibility.
AMD is one of the main diseases under investigation in the field of ophthalmology. Globally, the leading ophthalmological centres are working on the mission of improving current treatments for exudative AMD, advancing in prevention and in techniques of approach and discovering treatment for atrophic AMD. The Institut de la Màcula, in close collaboration with the Barcelona Macula Foundation, forms part of a group that aspires to reverse the vision pathologies that until recently were developing inexorably.
* Institut Registration Code: E08607500. Clinical trial No. 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 Drug Research Ethics Committee (CEIm) of the Quironsalud Hospital Group in Barcelona.Dry or atrophic AMD