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

NCT02681783 | Unknown Phase 4

• 1 other identifier: PRaCTICAL 100-17
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

aflibercept

Outcome Measures

Primary Outcomes (1)

• Baseline aqueous humour cytokine levels in nAMD, CSR, and iPCV patients

  The primary outcome is to compare the baseline aqueous inflammatory cytokine levels (pg/ml) and baseline aqueous cortisol levels (pg/ml) through analyzing anterior chamber aqueous fluid in patients with nAMD, CSR, and iPCV patients receiving aflibercept intravitreal injections, and compare with the aquueous fluid of age-matched control patients undergoing cataract surgery.

  4 months from baseline intervention

Secondary Outcomes (2)

• Assessment of the intra-group changes in best-corrected visual acuity using Snellen eye charts after aflibercept treatment in patients with nAMD, CSR, and iPCV for 4 months

  4 months from baseline intervention

• Assessment of the intra-group changes in anatomical changes via OCT imaging from baseline after aflibercept treatment in patients with nAMD, CSR, and iPCV for 4 months

  4 months from baseline intervention

Study Arms (4)

neovascular AMD group with PED

ACTIVE COMPARATOR

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.

Drug: aflibercept

CSR group with PED

EXPERIMENTAL

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.

Drug: aflibercept

iPCV group with PED

EXPERIMENTAL

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.

Drug: aflibercept

cataract patients

NO INTERVENTION

Patients diagnosed with cataracts requiring cataract surgery will serve as study controls. No intervention will be applied to these patients.

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).

Also known as: Eylea

CSR group with PED; iPCV group with PED; neovascular AMD group with PED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.
• Ocular or periocular infection
• Active intraocular inflammation

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Central Serous Chorioretinopathy; Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Retinal Degeneration

Study Officials

• Radha P. Kohly, MD PhD FRCSC

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radha P. Kohly, MD PhD FRCSC

CONTACT

4164805607; radha.kohly@sunnybrook.ca

Cindy Rutz

CONTACT

416-480-5091; cindy.rutz@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Toronto

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 12, 2016
• Study Start: December 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

CA (1)