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

NCT01710332 | Completed Phase 2 Results

• 2 other identifiers: CSRII20121564
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Central Serous Chorioretinopathy

Keywords

Persistent; Central; Serous; Chorioretinopathy; Regeneron; CSR; CSCR

Outcome Measures

Primary Outcomes (1)

• Safety of Intravitreal Aflibercept Injection

  Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.

  6 months

Secondary Outcomes (1)

• Change in Vision Based on Letter Score

  6 months

Study Arms (2)

Intravitreal Aflibercept Injection (x4)

EXPERIMENTAL

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

Drug: Intravitreal Aflibercept Injection

Intravitreal Aflibercept Injection (x6)

EXPERIMENTAL

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

Drug: Intravitreal Aflibercept Injection

Interventions

Intravitreal Aflibercept Injection 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).

Also known as: Eylea

Intravitreal Aflibercept Injection (x4); Intravitreal Aflibercept Injection (x6)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wills Eye: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

Mid Atlantic Retina- Huntingdon Valley

Huntingdon Valley, Pennsylvania, 19006, United States

Location

Mid Atlantic Retna- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• 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.

  PMID: 40522203 DERIVED

• 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.

  PMID: 25595177 DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Allen C. Ho, MD
• Organization: Mid Atlantic Retina

mformoso@midatlanticretina.com

215-459-0477

Study Officials

• Allen Ho, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 19, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 16, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)