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

NCT ID: NCT01710332

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-06-30

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

Conditions

Central Serous Chorioretinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravitreal Aflibercept Injection (x4)

2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).

Group Type: EXPERIMENTAL

Intravitreal Aflibercept Injection

Intervention Type: DRUG

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).

Intravitreal Aflibercept Injection (x6)

2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).

Group Type: EXPERIMENTAL

Intravitreal Aflibercept Injection

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Eylea

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Wills Eye

OTHER

Sponsor Role: lead

Responsible Party

Allen C. Ho, MD

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allen Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Mid Atlantic Retina- Huntingdon Valley

Huntingdon Valley, Pennsylvania, United States

Mid Atlantic Retna- Wills Eye Institute

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40522203 (View on PubMed)

Pitcher 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.

Reference Type: DERIVED

PMID: 25595177 (View on PubMed)

Other Identifiers

20121564

Identifier Type: OTHER

Identifier Source: secondary_id

CSRII

Identifier Type: -

Identifier Source: org_study_id