Impact of Intravitreal Pegcetacoplan Treatment on Systemic Complement Levels in Age Related Macular Degeneration: A pilot study
Amir Hajrasouliha
Primary Investigator
Brief description of study
What is the purpose of this study?
This study aims to understand how a new eye treatment, Pegcetacoplan, affects levels of certain proteins in the blood (complement proteins) that are linked to age-related macular degeneration and to measure the progression rate of the disease based on OCT landmarks using standard pretrained AI model. By tracking these changes, we hope to identify ways to predict how well patients with age-related macular degeneration will respond to the treatment and improve outcomes for both eyes.
Detailed description of study
What will happen during the study?
5.1 A cohort of 20 patients diagnosed with geographic atrophy (GA), in which they are scheduled to receive Pegcetacoplan injections will be recruited based on inclusion criteria.
5.2 From the cohort described above, a single peripheral blood draw will be first performed prior to first intravitreal Pegcetacoplan injection.
5.3 Blood sample (about 6 teaspoons or 30 ml) will be collected and divided in two different types of collection tubes (Gold Top Tube or Serum Separator Tube (SST) and Lavender or purple top tubes EDTA). Each tube will be properly labeled with patient name, DOB, test and collect date.
5.4 Blood samples collected will be sent to our local IU Health laboratory services to quantify key complement components, specifically C3, C5, and C5b-9
5.5 Other similar peripheral blood draws will be performed on day 3, day 7, month 1, and month 2 (the next visit day before new injection)
5.6 In addition, patients will undergo comprehensive ocular assessment as part of their standard eye care including visual acuity test, intraocular pressure measurement (IOP), slit lamp biomicroscopic exam, dilated fundus exam, fundus photography, fundus autofluorescence, optical coherence tomography (OCT), and optical coherence tomography angiography (OCTA) for both the treated and untreated eyes.
5.7 These evaluations will be performed at baseline and at subsequent follow-up visits every other month. The patients will be followed for at least one year.
5.8 The OCT images will be segmented and measured by the Altris, an FDA cleared AI-platform for segmentation and classification of OCT image, applicable for many retinal conditions. OCT image parameters including total GA area, ellipsoid zone disruption, RPE loss, hyper reflective foci, hyper transmission areas and ELM discontinuity will be measured at baseline and follow up images.
5.9 The OCTA images will be analyzed by the AngioTools, a FIJI (advanced version of ImageJ) plug-in for quantitative vascular structure analyses.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Age-Related Macular Degeneration
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
- Similar to original trials of OKS and DERBY (phase 3, multicenter, randomized trials)
patients with GA secondary to dry AMD with vision 20/320 or better with any lesion equal to 1.25 mm2 or larger on fundus autofluorescence (FAF) will be included - ability to cooperate with imaging procedures
- willingness to receive Pegcetacoplan (an FDA approved treatment for GA) as part of the standard treatment of GA related to AMD.
- No previous history of treatment with anti-complement agents
Exclusion Criteria
- presence of CNV
- diabetic retinopathy
- retinal vein and artery occlusion
- retinal detachment
- glaucoma
- uveitis
- systemic disease including rheumatologic disorders and other systemic process that can affect complement level
