The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Intervention: Intravitreal Aflibercept Injection
Intervention description: 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).
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Persistent; Central; Serous; Chorioretinopathy; Regeneron; CSR; CSCR

Summary:

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

Eligibility 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.