Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection.

Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection. - Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000020326

Enrollment

Registered

2016-03-08

Start date

2017-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Macular edema secondary to retinal vein occlusion (RVO)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Center-involving macular edema secondary to BRVO or CRVO 2) Central Retinal Thickness (CRT) more than 250 3) Patient age of 18 years or more

Exclusion criteria

Exclusion criteria: 1) Previous history of vitreoretinal surgery 2) Previous history of ophthalmic disorders except mild refractive errors and mild cataract 3) Within 90 days of macular edema treatment [ including sub-Tenon triamcinolone acetonide (STTA), intravitreal bevacizumab (IVB), intravitreal ranibizumab (IVR), intravitreal aflibercept (IVA), topical steroid, carbonic anhydrase inhibitors (CAI) ] 4) Within 90 days of intraocular surgery 5) Contralateral eye of RVO 6) Poor control of hypertension (HT) and diabetic mellitus (DM) 7) Within 30 days of laser treatment

Design outcomes

Primary

Measure	Time frame
Mean change in horizontal and vertical metamorphopsia scores using M-charts from baseline at Month 12.	—

Secondary

Measure	Time frame
Mean change in BCVA from baseline at Month 12 Mean change in contrast sensitivity from baseline at Month 12 Mean change in central macular thickness (CRT) from baseline at Month 12 Presence/absence of inner retinal cyst over time until Month 12 Mean change in thickness of inner retinal layer from baseline at Month 12 Mean change in VR-QOL (subscale and composite scores in NEI VFQ-25) at Month 0,3,6 and 12 Adverse events (AEs) and Serious adverse events (SAEs)	—

Measure

Time frame

Mean change in BCVA from baseline at Month 12 Mean change in contrast sensitivity from baseline at Month 12 Mean change in central macular thickness (CRT) from baseline at Month 12 Presence/absence of inner retinal cyst over time until Month 12 Mean change in thickness of inner retinal layer from baseline at Month 12 Mean change in VR-QOL (subscale and composite scores in NEI VFQ-25) at Month 0,3,6 and 12 Adverse events (AEs) and Serious adverse events (SAEs)

—

Countries

Japan

Contacts

Public ContactFumiki Okamoto

University of Tsukuba Department of Ophthalmology, Faculty of Medicin

fumiki-o@md.tsukuba.ac.jp029-853-3148

Outcome results