Effect of Alternate Treatment with Intravitreal Anti-Vascular Endothelial Growth Factor and Corticosteroid for Macular Edema

Effect of Alternate Treatment with Intravitreal Anti-Vascular Endothelial Growth Factor and Corticosteroid for Diabetic Macular Edema and Macular Edema Secondary to Retinal Vein Occlusion - A randomized prospective open-label controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007766

Enrollment

188

Registered

2022-09-30

Start date

2022-09-20

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients will be randomly allocated into two groups as follows: 1) intravitreal anti-VEGF monotherapy (anti-VEGF group), 2) alternate treatment with intravitreal anti-VEGF and corticosteroid (a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - CRT = 300 um due to DME or ME secondary to RVO at the time of screening. - Best corrected visual acuity (BCVA) 20/32~20/200 at the time of screening .

Exclusion criteria

Exclusion criteria: Excluded if any of the following criteria are met - If there is a history of intravitreal anti-VEGF or corticosteroid injection within 3 months of screening. - In case of receiving systemic anti-VEGF or corticosteroid treatment within 3 months of screening. - In the case of receiving panretinal photocoagulation treatment within 3 months of screening. - In the case of receiving corticosteroid eye drop treatment within 3 months of screening. - If there is a history of idiopathic or autoimmune uveitis in the trial or the disease is confirmed at the time of screening. - If you have had intraocular surgery except for simple cataract surgery. - If there is a history of glaucoma in the trial or the disease is confirmed at the time of screening. - If there is a history of retinal diseases other than diabetic retinopathy and retinal vein occlusion in the trial, or the disease is confirmed at the time of screening.

Design outcomes

Primary

Measure	Time frame
Mean change of BCVA from the baseline	—

Secondary

Measure	Time frame
Mean change of BCVA from the baseline;Mean change of CRT from the baseline;Mean change of CRT from the baseline;Change of aqueous humor cytokine level from the baseline;Change of aqueous humor cytokine level from the baseline;Proportion of subjects with an absence of intraretinal or subretinal fluid;Proportion of subjects with an absence of intraretinal or subretinal fluid;Number of intravitreal injections performed during the treatment period (12 months)	—

Measure

Time frame

Mean change of BCVA from the baseline;Mean change of CRT from the baseline;Mean change of CRT from the baseline;Change of aqueous humor cytokine level from the baseline;Change of aqueous humor cytokine level from the baseline;Proportion of subjects with an absence of intraretinal or subretinal fluid;Proportion of subjects with an absence of intraretinal or subretinal fluid;Number of intravitreal injections performed during the treatment period (12 months)

—

Countries

Korea, Republic of

Contacts

Public ContactDAE JOONG MA

Hallym University Medical Center-Kangnam

daejoongma@hallym.or.kr+82-2-6960-1240

Outcome results