Central Serous Chorioretinopathy
Conditions
Keywords
Persistent, Central, Serous, Chorioretinopathy, Regeneron, CSR, CSCR
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
Interventions
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).
Sponsors
Regeneron Pharmaceuticals
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Intravitreal Aflibercept Injection | 6 months | Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vision Based on Letter Score | 6 months | • Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravitreal Aflibercept Injection (x4) 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
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). | 6 |
| Intravitreal Aflibercept Injection (x6) 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
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). | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Intravitreal Aflibercept Injection (x6) | Intravitreal Aflibercept Injection (x4) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Continuous | 53.5 years STANDARD_DEVIATION 9.6 | 53.8 years STANDARD_DEVIATION 12.8 | 53.7 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Safety of Intravitreal Aflibercept Injection
Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravitreal Aflibercept Injection (x4) | Safety of Intravitreal Aflibercept Injection | 0 adverse events |
| Intravitreal Aflibercept Injection (x6) | Safety of Intravitreal Aflibercept Injection | 0 adverse events |
Secondary
Change in Vision Based on Letter Score
• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreal Aflibercept Injection (x4) | Change in Vision Based on Letter Score | -0.3 ETDRS letters | Standard Deviation 12.4 |
| Intravitreal Aflibercept Injection (x6) | Change in Vision Based on Letter Score | 4.7 ETDRS letters | Standard Deviation 13.4 |