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

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Brief Title

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

Official Title

PRedictive Factors and Changes From Treatment in Idiopathic Polypoidal Choroidal Vasuclopathy Versus Central Serous Chorioretinopathy Versus Neovascular Age Related Macular Degeneration With afLibercept

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.
    

Detailed Description

      The presence of Pigment Epithelial Detachments (PEDs) in neovascular Age-related Macular
      Degeneration (nAMD), Central serous chorioretinopathy (CSR) and idiopathic Poplypoidal
      Choroidal Vasculopathy (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. In nAMD, growth factors and
      cytokines, such as vascular endothelial growth factor (VEGF), pigment epithelium derived
      factor (PEDF), interleukin 6 (IL-6) and placenta growth factor (PLGF) are known to play an
      important role in the development of CNV angiogenesis. Aqueous samples from CSR eyes have
      been analyzed for various growth factors and cytokines, where levels of interlukin (IL)-6,
      IL-8 and monocyte chemoattractant protein-1 do not differ from healthy controls, and
      platelet-derived growth factor (PDGF) levels appear to be lower than controls. In addition,
      there is evidence to demonstrate that CSR is associated with elevated cortisol serum levels.
      Cortisol has been analyzed in the aqueous humor of glaucoma and cataract patients; however,
      the presence of cortisol in aqueous humor in CSR patients has not yet been identified. One
      study comparing iPCV versus controls found elevated levels of IL-23. Cytokines have also been
      compared between nAMD and iPCV showing elevated levels of CRP and IL-10 in eyes with iPCV or
      nAMD. However, there have not been any studies yet comparing aqueous cytokine levels,
      including PLGF between iPCV, CSR, and nAMD patients. This information may be useful in
      creating a diagnostic aqueous cytokine and hormone profile to differentiate between nAMD, CSR
      and iPCV.

      If left untreated, PEDs associated with nAMD, CSR, and iPCV may lead to the loss of central
      vision. We propose to compare the effectiveness of aflibercept in the treatment of PEDs
      associated with nAMD, CSR and iPCV.

      The primary goal of this study is to compare baseline aqueous cytokine and cortisol levels
      between nAMD, CSR, and iPCV participants and age-matched cataract controls. We will not be
      looking at changes in cytokine levels after treatment. The secondary objective is to assess
      intra-group changes in visual and anatomical outcomes in nAMD, CSR and iPCV participants with
      PED treated with aflibercept and correlate these changes to baseline cytokines.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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

Condition

Central Serous Chorioretinopathy

Intervention

aflibercept

Study Arms / Comparison Groups

 neovascular AMD group with PED
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

90

Start Date

December 1, 2018

Completion Date

December 1, 2022

Primary Completion Date

December 1, 2022

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Radha P. Kohly, MD PhD FRCSC, 4164805607, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02681783

Organization ID

PRaCTICAL 100-17


Responsible Party

Principal Investigator

Study Sponsor

Sunnybrook Health Sciences Centre


Study Sponsor

Radha P. Kohly, MD PhD FRCSC, Principal Investigator, Sunnybrook Health Sciences Center


Verification Date

January 2021