Recruiting

iPCV vs. CSR vs. nAMD

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02681783

Conditions

Central Serous Chorioretinopathy

Age Related Macular Degeneration

Idiopathic Poplypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

aflibercept

Study Details

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

Study ID

NCT02681783

Start date

Dec 1, 2018

Status verified date

Jan, 2021

Completion date

Dec 1, 2022

Anticipated

Primary completion date

Dec 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

aflibercept

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Radha P. Kohly, MD PhD FRCSC

4164805607radha.kohly@sunnybrook.ca

Cindy Rutz

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

Locations

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Radha Kohly, MD, PhD, FRCSC

416-480-5607radha.kohly@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jan 28, 2021

Last verified

Jan, 2021

Keywords

  • aflibercept

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2021-01-28.