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The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy (CONTAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01710332
Recruitment Status : Completed
First Posted : October 19, 2012
Results First Posted : April 7, 2017
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Allen C. Ho, MD, Wills Eye

Brief Summary:
A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.

Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Drug: Intravitreal Aflibercept Injection Phase 2

Detailed Description:
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Study Start Date : October 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravitreal Aflibercept Injection (x4)
2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Drug: Intravitreal Aflibercept Injection

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).

Other Name: Eylea

Experimental: Intravitreal Aflibercept Injection (x6)
2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
Drug: Intravitreal Aflibercept Injection

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).

Other Name: Eylea




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Vision Based on Letter Score [ Time Frame: 6 months ]
    • Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710332


Locations
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United States, Pennsylvania
Mid Atlantic Retina- Huntingdon Valley
Huntingdon Valley, Pennsylvania, United States, 19006
Mid Atlantic Retna- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Regeneron Pharmaceuticals
Investigators
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Principal Investigator: Allen Ho, MD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allen C. Ho, MD, Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01710332    
Other Study ID Numbers: CSRII
20121564 ( Other Identifier: Western IRB )
First Posted: October 19, 2012    Key Record Dates
Results First Posted: April 7, 2017
Last Update Posted: June 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Allen C. Ho, MD, Wills Eye:
Persistent
Central
Serous
Chorioretinopathy
Regeneron
CSR
CSCR
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases