PRedictive Factors and Changes From Treatment in iPCV Versus CSR Versus nAMD With afLibercept (NCT02681783) | Clinical Trial Compass
UnknownPhase 4
PRedictive Factors and Changes From Treatment in iPCV Versus CSR Versus nAMD With afLibercept
Canada90 participantsStarted 2018-12-01
Plain-language summary
The presence of PEDs in nAMD, CSR and iPCV can present a diagnostic challenge in the elderly population; despite detailed diagnostic testing to differentiate these three conditions, misdiagnosis and mistreatment still occurs. One potential way of differentiating these three conditions might be to compare cytokine profiles in nAMD versus CSR versus iPCV. This information may be useful in creating a diagnostic aqueous cytokine and hormone profile to differentiate between nAMD, CSR and iPCV.
The primary goal of this study is to compare baseline aqueous cytokine and cortisol levels between nAMD, CSR, and iPCV patients and age-matched cataract controls. The secondary objective is to assess intra-group changes in visual and anatomical outcomes in nAMD, CSR and iPCV patients with PED treated with aflibercept and correlate these changes to baseline cytokines.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older
✓. Ability to provide signed informed consent
✓. Capable of complying with study protocol and required diagnostic tests
✓. Meets study eye criteria for each respective group (see Section 5 above)
✓. Participants in the nAMD, CSR, and iPCV groups must use an acceptable method of birth control during this study and for 6 months following completion of the study. The participants in the control group will not be receiving IP and are not required to meet this inclusion criterion.
Exclusion criteria
✕. Previous intraocular injections including anti-VEGF therapy or steroid medication, or macular laser for all groups
✕. Any co-existing maculopathy or retinopathy in the study eye
✕. Participants with a history of either type I or type II diabetes
✕. Intraocular surgery in the study eye within the past 4 months
What they're measuring
1
Baseline aqueous humour cytokine levels in nAMD, CSR, and iPCV patients
✕. Currently on systemic steroid therapy in any form (drops, skin creams, inhalation/intranasal sprays, intravenous) or immunosuppression for the last 3 months
✕. Participants on renal dialysis
✕. Pregnant and nursing mothers
✕. Participants who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.