Overview

PRedictive Factors and Changes From Treatment in iPCV Versus CSR Versus nAMD With afLibercept

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sunnybrook Health Sciences Centre

Treatments:

Aflibercept

Criteria

Inclusion criteria for all study eye groups:

1. 18 years of age or older

2. Ability to provide signed informed consent

3. Capable of complying with study protocol and required diagnostic tests

4. Meets study eye criteria for each respective group (see Section 5 above)

5. 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 for all study eye groups:

1. Previous intraocular injections including anti-VEGF therapy or steroid medication, or
macular laser for all groups

2. Any co-existing maculopathy or retinopathy in the study eye

3. Participants with a history of either type I or type II diabetes

4. Intraocular surgery in the study eye within the past 4 months

5. Currently on systemic steroid therapy in any form (drops, skin creams,
inhalation/intranasal sprays, intravenous) or immunosuppression for the last 3 months

6. Participants on renal dialysis

7. Pregnant and nursing mothers

8. Participants who are hypersensitive to this drug, to any ingredient in the
formulation, or to any component of the container.

9. Ocular or periocular infection

10. Active intraocular inflammation