Age-Related (Dry) Macular Degeneration
Conditions
Keywords
geographic atrophy, AMD
Brief summary
Study to evaluate the safety of routine diagnostic anterior chamber paracentesis (ACP) for proteomic profiling in patients with geographic atrophy (GA)
Detailed description
The primary objective of this study is to assess the safety and tolerability of serial (two) AC paracentesis procedures, performed at Baseline and Month 1, for the collection of AH in subjects with Geographic Atrophy (GA) or dry Age-Related Macular Degeneration (dAMD).
Interventions
PROCEDUREAC Tap (anterior chamber paracenthesis)
anterior chamber paracenthesis (microvolume of eye fluid is taken)
Sponsors
ClinOmicsAI
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects aged between 50 and 89 years, inclusive * For the GA cohort: Clinical diagnosis of GA secondary to AMD or dAMD in the study eye, confirmed by fundus autofluorescence imaging and spectral-domain optical coherence tomography (SD-OCT). * For the control cohort: No clinical evidence of retinal disease in either eye. * Best-corrected visual acuity (BCVA) of ≥20/200 in the study eye, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) charts * Ability and willingness to provide written informed consent before any study-specific procedures.
Exclusion criteria
* Presence of active ocular infection or inflammation in either eye at the time of screening. * History of intraocular surgery in the study eye within the three months preceding enrollment. * Intraocular pressure (IOP) greater than 21 mmHg in the study eye at screening * Use of systemic anticoagulation therapy that cannot be safely discontinued prior to ACP. * Pregnant or nursing women. * Known hypersensitivity or contraindication to any of the medications or procedures used in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | From enrollment to end of Visit 2 | Incidence of Treatment-Emergent Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal changes in the Aqueous Humor proteome between Baseline (Day 0) and Month 1 (Day 30) | From Baseline (Day 0) to Month 1 (Day 30) | The secondary objective of this study is to characterize longitudinal changes in the AH proteome between Baseline (Day 0) and Month 1 (Day 30) by analyzing AH specimens collected at these two time points. |
Countries
United States
Outcome results
None listed