Central Serous ChorioretinopathyPhase 4PRaCTICALNCT02681783
PRedictive Factors and Changes From Treatment in iPCV Versus CSR Versus nAMD With afLibercept
A Phase 4 study testing aflibercept in people with Central Serous Chorioretinopathy and Age Related Macular Degeneration, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Serous Chorioretinopathy, Age Related Macular Degeneration, Idiopathic Poplypoidal Choroidal Vasculopathy
- What is being tested?
- aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2018to 1 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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)
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Radha Kohly, MD, PhD, FRCSC, 416-480-5607, radha.kohly@sunnybrook.ca
About this study
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
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.
Read the 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.
- Conditions
- Central Serous Chorioretinopathy, Age Related Macular Degeneration, Idiopathic Poplypoidal Choroidal Vasculopathy
- Being tested
- aflibercept
- Keywords
- aflibercept
- Medical subject headings
- Central Serous Chorioretinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afliberceptDrug
Also called Eylea
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To assess 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
Measured: 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
To assess 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
Measured: 4 months from baseline intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study start1 Dec 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Radha Kohly, Sunnybrook Health Sciences Centre
- Investigators
- Radha P. Kohly, MD PhD FRCSC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681783
- Sponsor's protocol ID
- PRaCTICAL 100-17
- Acronym
- PRaCTICAL
- Status last verified
- Jan 2021
- First submitted
- 12 Feb 2015
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02681783
- Acronym / sponsor ID
- PRaCTICAL / PRaCTICAL 100-17
- Conditions
- Central Serous Chorioretinopathy, Age Related Macular Degeneration, Idiopathic Poplypoidal Choroidal Vasculopathy
- Keywords
- aflibercept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| neovascular AMD group with PED | Active comparator | Drug: afliberceptPatients 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. |
| CSR group with PED | Experimental | Drug: afliberceptPatients 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. |
| iPCV group with PED | Experimental | Drug: afliberceptPatients 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. |
| cataract patients | No intervention | –Patients diagnosed with cataracts requiring cataract surgery will serve as study controls. No intervention will be applied to these patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| afliberceptAlso: EyleaTherapeutic/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). | Drug | CSR group with PED, iPCV group with PED, neovascular AMD group with PED |
Primary outcome
Baseline aqueous humour cytokine levels in nAMD, CSR, and iPCV patients
Time frame: 4 months from baseline intervention
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.
2 secondary outcomes
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
Time frame: 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
Time frame: 4 months from baseline intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radha P. Kohly, MD PhD FRCSC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aflibercept in people with Central Serous Chorioretinopathy and Age Related Macular Degeneration, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radha P. Kohly, MD PhD FRCSC (4164805607, radha.kohly@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline aqueous humour cytokine levels in nAMD, CSR, and iPCV patients (time frame: 4 months from baseline intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021; AzTrials last refreshed its copy on 2 Nov 2026.