Age-Related Macular Degeneration
ASCENT: A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX 314 Gene Therapy in Participants with nAMD.
Eye condition/Study type:
Neovascular Age-Related Macular Degeneration (Wet AMD)
Principal Investigator:
Professor Dominik Fischer
This phase 3, partially masked, randomized, multicentre study has two periods: an Active Run-in Period and an Assessment Period. Participants receiving ABBV-RGX-314 will be encouraged to join a long-term follow-up (LTFU) study (RGX-314-5101) after completing or discontinuing this study, signing separate consent for the LTFU. The Active Run-in Period (up to 6 weeks) begins after informed consent and ends after eligibility evaluation, ranibizumab injection (0.5 mg at Week -6), anatomic response evaluation (Week -5), and aflibercept injection (2 mg at Week -2). The Assessment Period starts after randomization and lasts up to 1 year, or 2 years for crossover participants.
https://studies.ouh.nhs.uk/project_detail/9845/
Currently recruiting. If interested, please contact via email ERGO@ouh.nhs.uk
PARASOL A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD).
Eye condition/Study type:
Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Principal Investigator:
Professor Dominik Fischer
This clinical trial is testing a gene therapy called JNJ-81201887 (AAVCAGsCD59) for treating geographic atrophy (GA) due to age-related macular degeneration (AMD) compared to sham control. The therapy uses a virus to deliver a gene that could help protect the retina from damage. The trial will evaluate how safe and effective this treatment is for slowing or stopping vision loss in participants with GA. If successful, this therapy could offer a new option for those with limited treatments available.
Closed to recruitment/in follow up
ATHENA: Optical Coherence Tomography Angiography for the detection of Neovascular Age-related Macular Degeneration: a Comprehensive Diagnostic Accuracy Study.
Eye condition/Study type:
Neovascular Age-Related Macular Degeneration (Wet AMD)
Principal Investigator:
Miss Samantha de Silva
This study investigates the best method to confirm neovascular age-related macular degeneration (nAMD), a common eye condition affecting people over 50. Diagnosis usually involves examining the back of the eye, often with Fluorescein Angiography (FA), which detects dye leakage but is labour-intensive and sometimes inconclusive. In such cases, Indocyanine-Green Angiography (ICGA) is added, especially if Polypoidal Choroidal Vasculopathy (PCV) is suspected. Newer techniques, such as Optical Coherence Tomography (OCT), quickly scan the eye and, alongside clinical examinations, are now preferred. Optical Coherence Tomography-Angiography (OCTA), which shows retinal blood flow, may potentially replace FA for diagnosis.
https://studies.ouh.nhs.uk/project_detail/9603/
Closed to recruitment/in follow up
The PINNACLE Study: Deciphering AMD by deep phenotyping and machine learning.
Eye condition/Study type:
Intermediate age-related macular degeneration
Principal Investigator:
Prof. Susan Downes
This study aims to improve predictions of which patients with age-related macular degeneration (AMD) will experience vision loss by using machine learning to analyse high-resolution eye images. By examining 400 AMD patients over three years, the study will identify patterns that could indicate disease progression. Blood samples will also be taken for genetic testing to explore factors influencing disease development. The goal is to enhance treatments, clinical trial selection, and understanding of AMD progression.
https://studies.ouh.nhs.uk/project_detail/8038/
Closed to recruitment/in follow up
TIGER: Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative Age-Related macular degeneration - a phase 3, pan-European, two-group, active-control, observer-masked, superiority, randomised controlled surgical trial.
Eye condition/Study type:
Submacular haemorrhage secondary to wet age-related macular degeneration
Principal Investigator:
Mr Sher Aslam
This study aims to compare two treatments for wet age-related macular degeneration (AMD) and submacular haemorrhage (SMH): standard anti-VEGF injections and the combination of anti-VEGF injections with surgery. The goal is to determine if adding surgery to the standard anti-VEGF treatment can improve vision outcomes beyond the current standard, which primarily addresses fluid leakage but not the underlying SMH. The study will evaluate whether the additional surgical approach offers significant benefit for patients with SMH and wet AMD.
Currently recruiting. If interested, please contact via email ERGO@ouh.nhs.uk
OKKO Study: Exploring the feasibility of the OKKO Health app to monitor and predict disease activity caused by age-related macular degeneration.
Eye condition/Study type:
Age-related macular degeneration
Principal Investigator:
Professor. Susan Downes
Macular disease is the leading cause of blindness in the UK and patients with age-related macular degeneration must undergo regular monitoring to determine if an injection into the eye is required [required in 50% of visits]. These patients are very frequent attenders within ophthalmology units, visiting specialist hospital clinics on a monthly or bi-monthly basis. This project aims to create a home-monitoring algorithm that could in the future, enable the transfer of 'monitoring' of chronic eye disease from the hospital eye service into the patients' home. Thus, remotely identifying individuals who do not need an in-person appointment.
Closed to recruitment/in follow up
ORACLE: A long-term follow-up study to evaluate the safety of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study.
Eye condition/Study type:
Geographic atrophy secondary to age-related macular degeneration (dry AMD), have received GT005 gene therapy in previous trial
Principal Investigator:
Mr Kanmin Xue
GT005, a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding human complement factor I, is being developed as a gene therapy for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Current regulatory guidelines recommend that participants in gene therapy trials using non-replicating, non-integrating viral vectors with no known potential for latency or reactivation be followed for approximately 5 years post-treatment. The GT-ORACLE study aims to evaluate the long-term safety and durability of GT005 for up to 5 years. Participants from the GT005-02 (EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445) studies will be invited to enrol.
https://studies.ouh.nhs.uk/project_detail/9631/
Closed to recruitment/in follow up