Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema

CompletedOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

August 1, 2017

Primary Completion Date

February 1, 2018

Study Completion Date

March 1, 2019

Conditions
Diabetic Macular Edema
Interventions
DRUG

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

"PRN regimen. Treatment Schedule Repeat injections at every 4-week visit if eye improves or worsens (defined as ≥5 letter change from last injection or ≥10% CST change on OCT from last injection or CSF\>300 μm at any timepoint).~Defer injections if either BCVA of 85 letters and OCT CSF normal (CSF≤300 μm and non-existent intra- or sub-retinal fluid); or OCT CSF normal (CSF≤300 μm) and stable BCVA (defined as \< 5 letters change from last injection) after two consecutive injections during the first 24 weeks, or after one injection if the initial stability period has already been achieved (OCT CSF normal and stable BCVA).~Resume injections if BCVA or OCT worsens."

Trial Locations (1)

Unknown

Hospital de Santo António, Porto

All Listed Sponsors
lead

Centro Hospitalar do Porto

OTHER

NCT04387604 - Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema | Biotech Hunter | Biotech Hunter