A Study in Adults With Geographic Atrophy
ConditionGeographic Atrophy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorSitala Bio LTD
About this trial
The purpose of this clinical research study is to look at how safe STL303 is and whether it works when given to people with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). Geographic atrophy secondary to AMD is a condition where cells in the back part of the eye slowly die, causing a blurry, or missing spot in the centre of vision.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants ≥60 years of age at the time of Screening (signing the ICF).
Diagnosis of non-exudative AMD in both eyes, with confirmed presence of phenotypic hallmarks of AMD such as hard and/or soft drusen.
Total GA area must be ≥2.5 and ≤10.16 mm2 (1 and 4 DA, respectively) as measured using SD-OCT.
If GA is multifocal, at least one focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above in 3a.
Disqualifiers
Atrophic retinal disease of causality other than AMD including myopia-related maculopathy and macular dystrophies such as pattern dystrophy and Stargardt disease in either eye.
Evidence of ongoing exudative AMD, polypoidal choroidal vasculopathy, or macular neovascularisation in either eye by history, OCT, fluorescein angiography (FA) or optical coherence tomography angiography (OCTA) as determined by the Reading Centre (prior IVT treatment for CNV is permitted in the fellow eye so long as the last injection was more than two years previously).
Previous treatment with any ocular photodynamic therapy or laser coagulation to the macula in the study eye.
Presence of active/current retinal vein occlusion in the study eye.
Trial design
Design model
Parallel
Treatments tested in this trial
STL303
DrugSTL303 arm participants will receive a specific dose of STL303
Placebo
DrugPlacebo arm participants will receive placebo
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: STL303 dose level 1Experimental treatment 1 intervention
Group B: STL303 dose level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduction of rate of total EZ area loss
Rate of change in the area of photoreceptor loss
Time frame
From baseline to Week 52Secondary outcomes
1
Number of reported treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)
Assess safety and tolerability of STL303
Time frame
Baseline to week 1082
Change in Retinal sensitivity
Mesopic microperimetry using participant-customised peri-lesional grid.
Time frame
From enrolment to end of treatment at week 1043
Rate of disease progression (photoreceptor loss)
Rate of change in the area of photoreceptor loss (defined as ellipsoid zone to retinal pigment epithelium thickness of 0 μm) in the study eye, as assessed by spectral-domain optical coherence tomography (SD-OCT)
Time frame
From enrolment to end of treatment at week 1044
Change in Vision-Related Quality of Life
Change from baseline in the National Eye Institute 25 item Visual Functioning Questionnaire (NEI VFQ-25). Range: 0-100, where higher scores indicate better vision-related quality of life.
Time frame
From Baseline to end of treatment at week 104Sponsors and contacts
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Source ClinicalTrials.gov