Visual Outcomes and the Predictive Factors in Chinese Patients With Diabetic Macular Edema Treated With Ranibizumab

Sponsor
Sun Yat-sen University
Study ID
NCT03973138
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    DME patients who were diagnosed through fundus manifestations and FFA examination were treated by intravitreal injections of ranibizumab (0.5mg Lucentis®; Genentech, South San Francisco, CA) under the pro re nata (PRN) treatment regimen. The retreatment were conducted if BCVA was reduced by 0.1 logarithm of the minimal angle of resolution (logMAR) value or more from maximum acuity or if OCT central subfield thickness was more than 300μm.

Study Details

The aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (DME).

Key Dates

First listed
Jun 4, 2019
Start date
Jan 1, 2015
Status verified
Jun 2019
Primary completion
Jan 1, 2020
Completion
Jan 1, 2020

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    DME patients who were diagnosed through fundus manifestations and FFA examination were treated by intravitreal injections of ranibizumab under the pro re nata (PRN) treatment regimen.

Primary Outcome Measure

Best-corrected visual acuity [ Time Frame: one year ]

Central Contacts

Related Studies