Central Serous ChorioretinopathyPhase 2CONTAINNCT01710332
The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy
A Phase 2 study testing Intravitreal Aflibercept Injection in people with Central Serous Chorioretinopathy, run by Wills Eye at 2 sites in United States.
Trial summary
A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Intravitreal Aflibercept Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pre-treatment acuity of 20/40- 20/320
- Macular fluid on optical coherence tomography for greater than 3 months
- Leakage on fluorescein angiography
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months prior to study enrollment
- Presence of choroidal neovascularization on enrollment imaging
- Prior vitrectomy in the study eye
- Presence of any substantial ocular disease (other than CSCR) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication)
Show all 15Show fewer
- Active ocular infection or inflammation in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Prior treatment with systemic anti-VEGF agents
- Cerebrovascular accident or myocardial infarction within the preceding 6 months.
- History of allergy to fluorescein, povidone iodine (Betadine) or aflibercept
- Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
- Pregnant or breast-feeding women Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- Contraception is not required for men with documented vasectomy.
- Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mid Atlantic Retina- Huntingdon Valley
Huntingdon Valley, Pennsylvania, 19006
Mid Atlantic Retna- Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.
Read the detailed description
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Intravitreal Aflibercept Injection
- Keywords
- Persistent, Central, Serous, Chorioretinopathy, Regeneron, CSR, CSCR
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept InjectionDrug
Also called Eylea
GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Aflibercept Injection (x4) | Experimental | 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). Receives: Drug: Intravitreal Aflibercept Injection |
| Intravitreal Aflibercept Injection (x6) | Experimental | 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times). Receives: Drug: Intravitreal Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Intravitreal Aflibercept Injection
Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
Measured: 6 months
Secondary outcomes (1)
Change in Vision Based on Letter Score
- Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Allen C. Ho, MD, Wills Eye
- Investigators
- Allen Ho, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710332
- Sponsor's protocol ID
- CSRII
- Other IDs
- 20121564
- Acronym
- CONTAIN
- Status last verified
- May 2017
- First submitted
- 16 Oct 2012
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
PubMed 40522203Pitcher JD 3rd, Witkin AJ, DeCroos FC, Ho AC. A prospective pilot study of intravitreal aflibercept for the treatment of chronic central serous chorioretinopathy: the CONTAIN study. Br J Ophthalmol. 2015 Jun;99(6):848-52. doi: 10.1136/bjophthalmol-2014-306018. Epub 2015 Jan 16.
PubMed 25595177
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT01710332
- Acronym / sponsor ID
- CONTAIN / CSRII
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Persistent, Central, Serous, Chorioretinopathy, Regeneron, CSR, CSCR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.
Detailed description
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Aflibercept Injection (x4) | Experimental | Drug: Intravitreal Aflibercept Injection2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). |
| Intravitreal Aflibercept Injection (x6) | Experimental | Drug: Intravitreal Aflibercept Injection2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pre-treatment acuity of 20/40- 20/320
- Macular fluid on optical coherence tomography for greater than 3 months
- Leakage on fluorescein angiography
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key exclusion criteria (15 listed)
- Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months prior to study enrollment
- Presence of choroidal neovascularization on enrollment imaging
- Prior vitrectomy in the study eye
- Presence of any substantial ocular disease (other than CSCR) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
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 |
|---|---|---|
| Intravitreal Aflibercept InjectionAlso: EyleaGROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total). | Drug | Intravitreal Aflibercept Injection (x4), Intravitreal Aflibercept Injection (x6) |
Primary outcome
Safety of Intravitreal Aflibercept Injection
Time frame: 6 months
Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
1 secondary outcome
Change in Vision Based on Letter Score
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40522203Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
- Derived from this study: PubMed 25595177Pitcher JD 3rd, Witkin AJ, DeCroos FC, Ho AC. A prospective pilot study of intravitreal aflibercept for the treatment of chronic central serous chorioretinopathy: the CONTAIN study. Br J Ophthalmol. 2015 Jun;99(6):848-52. doi: 10.1136/bjophthalmol-2014-306018. Epub 2015 Jan 16.
- Individual participant dataSharing planned: No
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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.
Allen Ho, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal Aflibercept Injection in people with Central Serous Chorioretinopathy, run by Wills Eye at 2 sites in United States.
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 15 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: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Intravitreal Aflibercept Injection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710332, which also lists 2 linked publications.
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 16 Jun 2017.