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

Related Clinical Trial
Eplerenone Versus PDT: Comparative Study by OCTA Pilot Study on Deep Learning in the Eye Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy OCT in Rare Chorioretinal Diseases Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO Selective RPE Laser Treatment (SRT) for Various Macular Diseases Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases Intravitreal Bevacizumab for the Treatment of Central Serous Chorioretinopathy Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC) Eye Patch Therapy for Central Serous Retinopathy (CSR) Multimodal Imaging in Central Serous Chorioretinopathy PRedictive Factors and Changes From Treatment in iPCV Versus CSR Versus nAMD With afLibercept Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy Pseudo-PDT in Central Serous Chorioretinopathy Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC) Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC) Selective Retina Therapy With Real-Time Feedback-Controlled Dosimetry for Treating Acute Idiopathic Central Serous Chorioretinopathy in Korean Patients Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Retinopathy Effects of OCTA-guided PDT in Acute CSC Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy Treatment Trial for Acute Central Serous Chorioretinopathy The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole Selective Retina Therapy With ‘R:GEN’ in Patients With Central Serous Chorioretinopathy 577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy Central Serous Chorioretinopathy: Etiology, Course and Prognosis A Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy Treatment of Chronic Central Serous Chorioretinopathy Via Electromagnetic Stimulation and Platelet- Rich Plasma Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy Eplerenone for the Treatment of Central Serous Chorioretinopathy Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy Optical Coherence Tomography Angiography (OCT-A) and Central Serous Chorioretinopathy (CSC) Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR) Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate Short-Term Oral Mifepristone for Central Serous Chorioretinopathy Methotrexate for Central Serous Chorioretinopathy Treatment Trial Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy Prospective Randomized Controlled Treatment Trial for Chronic Central Serous Chorioretinopathy The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy Eplerenone for Central Serous Chorioretinopathy High-dose Antioxidants for Central Serous Chorioretinopathy

Brief Title

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

Official Title

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

Brief Summary

      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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Safety of Intravitreal Aflibercept Injection

Secondary Outcome

 Change in Vision Based on Letter Score

Condition

Central Serous Chorioretinopathy

Intervention

Intravitreal Aflibercept Injection

Study Arms / Comparison Groups

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

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

12

Start Date

October 2012

Completion Date

June 2013

Primary Completion Date

June 2013

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.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Allen Ho, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01710332

Organization ID

CSRII

Secondary IDs

20121564

Responsible Party

Principal Investigator

Study Sponsor

Wills Eye

Collaborators

 Regeneron Pharmaceuticals

Study Sponsor

Allen Ho, MD, Principal Investigator, 


Verification Date

May 2017