None listed
Conditions
Interventions
Dietary Supplement : The treatment group takes Superoxide dismutase tablet, and the control group takes placebo one tablet per day for 48 weeks.
Sponsors
Ajou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age = 50 years 2) Capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements. 3) Patients who have received 3 times monthly intravitreal anti-vascular endothelial growth factor(Eylea) injection due to active choroidal subfoveal or juxtafoveal neovascularization lesions secondary to AMD, and who have been effective in treatment. 4) Patient who has recurred lesion after three consecutive monthly intravitreal Eylea injections. And patients more than two months after last intravitreal Eylea injection. 5) Patient who quit smoking for at least 3 months before screening. 6) The BCVA letter score of 35 to 85 using ETDRS charts in the study eye at visit 2(baseline).
Exclusion criteria
Exclusion criteria: 1) History of thrombotic events(stroke or myocardial infarction) within 3 month from the time of screening. 2) Uncontrolled hypertension defined as systolic blood pressure(BP) > 160 mmHg or diastolic BP >100 mmHg under appropriate antihypertensive treatment. 3) Hypersensitivity to Superoxide dismutase(SOD) tablet or medications used in this study (Aflibercept, mydriatic eye drops, etc.) 4) Patient who have gastrointestinal malabsorption that may affect the absorption of the test drug. 5) Patient who have a history of alcohol or drug abuse within 2 years from the time of screening. 6) Pregnancy or lactation during the entire clinical trial period for women of child-bearing potential. 7) Any contraindication for enrollment in this trial according to the investigator's clinical judgement. 8) Active intraocular/periocular infection or/and inflammation in either eye. 9) Intraocular pressure = 25mmHg in spite of anti-glaucoma treatment. 10) Subretinal hemorrhage that is either 50% or more of the total lesion area. 11) Scar or fibrosis, making up >50% of the total lesion in the study eye. 12) Any prior or concomitant treatment involving the macula with photodynamic therapy(PDT) with verteporfin within 3 months from the time of taking SOD tablet or placebo. Any prior or concomitant treatment with retinal laser treatment(eg, focal or grid pattern laser photocoagulation) in the study eye. 13) History or evidence of any other clinical significant disorder, condition or disease(eg, retinal detachment, significant epiretinal membrane, significant cataract, etc.) in the study eye. 14) History or clinical evidence of diabetic retinopathy (more than moderate nonproliferative diabetic retinopathy), diabetic macular edema in the study eye. 15) Axial length = 26 mm or spherical equivalent = -6 diopter. 16) Any prior or concomitant intravitreal corticosteroid injection within 6 months from the time of screening. 17) Any prior ocular surgery in the study eye within 3 months from the time of screening. 18) Prior vitrectomy in the study eye. 19) Any investigational product for the treatment of ocular conditions(in either eye) and/or systemic conditions 30 days or 5 half-lives (whichever is longer), prior to screening, and throughout the study, except dietary supplements or vitamins. 20) Any concomitant or prior treatment with deferoxamine; chloroquine/hydroxychloroquine; tamoxifen; phenothiazines; ethambutol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of times intravitreal Eylea injections during the clinical trial period, except baseline injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Central retinal thicknes change measured by SD-OCT;The proportion of clinical subjects who completely lost the intraretinal fluid and subretinal fluid identified as SD-OCT;BCVA change measured by ETDRS eye chart;The proportion of clinical subjects with visual acuity increase more than 5 letters.;The proportion of clinical subjects with visual acuity decrease more than 15 letters.;Blood level of MDA, C3d, Free thiol group and microbiome | — |
Countries
Korea, Republic of
Contacts
Public ContactKihwang Lee
Ajou University
Outcome results
None listed