Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      Patients will be included in two different groups according to the vitreous status: group 1 -
      non vitrectomized eyes; group 2 - vitrectomized eyes. Patients will be followed-up according
      to the standard of care and a final analysis of the results will be performed at 12+/-1
      months of follow-up, which is the minimum follow-up period required for each patient. In
      group 1 the effect of VMA existence and PVD status will also be analyzed. The recruitment
      period will be of 6 months.

      Treatment All patients will be treated with IV ranibizumab injections (0.5 mg/0.05ml)
      following a PRN regimen. The injections will be performed in the operating room following the
      standard intravitreal injections protocol. When required, adjunct treatment, with macular
      and/or peripheral LASER (rescue LASER), will be also admitted at or after 24 weeks if
      persistent DME not improving after at least 2 injections.

      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.
    

Intervention name(s): Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Ranibizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with DME followed on the ocular diabetes consultation of Centro Hospitalar e
        Universitário do Porto, Portugal, or Hospital Santa Maria Maior de Barcelos, Portugal,
        either non vitrectomized or vitrectomized.