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

Sponsor
Centro Hospitalar do Porto
Study ID
NCT04387604
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] — DRUG
    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.

Study Details

PURPOSE: To evaluate the effect of the vitreous in response to intravitreal (IV) injections of ranibizumab 0.5 mg/0.05ml (Lucentis; Genentech, South San Francisco, CA) for the treatment of diabetic macular edema (DME). METHODS: Prospective, observational, multicenter study, conducted at Centro Hospitalar e Universitário do Porto, Portugal. Best-corrected visual acuity and central foveal thickness will be evaluated at baseline and every month until the end of follow-up. OCT biomarkers such as retinal layers thickness will also be analyzed. A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Vitrectomized patients will improve less than non-vitrectomized patients.

Key Dates

First listed
May 14, 2020
Start date
Aug 1, 2017
Status verified
May 2020
Primary completion
Feb 1, 2018
Completion
Mar 1, 2019

Study Design

Enrollment
50 participants (actual)

Arms

  • Arm: non vitrectomized eyes
    ranibizumab injections (0.5 mg/0.05ml) following a PRN regimen
  • Arm: vitrectomized eyes
    ranibizumab injections (0.5 mg/0.05ml) following a PRN regimen

Primary Outcome Measure

assess the number of IV injections needed to control DME between groups [ Time Frame: 18 months ]

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