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

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT02681783
Phase
PHASE4
Status
Unknown

Conditions

  • Age Related Macular Degeneration
  • Central Serous Chorioretinopathy
  • Idiopathic Poplypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aflibercept — DRUG
    Therapeutic/Pharmacological Classification: VEGF - Anti-neovascularization agent Route(s) of Administration: Intravitreal Injection Dosage Form: Solution 40 mg/ml Proposed Indication: Treatment of Pigment Epithelial Detachments (PEDs) associated with neovascular Age-related Macular Degeneration (nAMD), Central serous chorioretinopathy (CSR), and idiopathic Poplypoidal Choroidal Vasculopathy (iPCV).

Study Details

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.

Key Dates

Start date
Dec 1, 2018
Status verified
Jan 2021
Primary completion
Dec 1, 2022
Completion
Dec 1, 2022

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: neovascular AMD group with PED
    Patients in this group will be administered aflibercept intravitreal injection 2 mg (0.05 mL), administered at baseline, month 1, and month 2, for a total of 3 injections. Study will end for these patients at month 4, where no injection will be given. A clinical exam and OCT imaging will be performed each visit.
  • Experimental: CSR group with PED
    Patients in this group will be administered aflibercept intravitreal injection 2 mg (0.05 mL), administered at baseline, month 1, and month 2, for a total of 3 injections. Study will end for these patients at month 4, where no injection will be given. A clinical exam and OCT imaging will be performed each visit.
  • Experimental: iPCV group with PED
    Patients in this group will be administered aflibercept intravitreal injection 2 mg (0.05 mL), administered at baseline, month 1, and month 2, for a total of 3 injections. Study will end for these patients at month 4, where no injection will be given. A clinical exam and OCT imaging will be performed each visit.
  • No Intervention: cataract patients
    Patients diagnosed with cataracts requiring cataract surgery will serve as study controls. No intervention will be applied to these patients.

Primary Outcome Measure

Baseline aqueous humour cytokine levels in nAMD, CSR, and iPCV patients [ Time Frame: 4 months from baseline intervention ]

Central Contacts

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