Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-05 @ 5:27 PM
Study NCT ID:
NCT04387604
Status:
COMPLETED
Last Update Posted:
2020-05-14
First Post:
2020-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema
Sponsor:
Centro Hospitalar do Porto
Organization:
Study Overview
Official Title:
Effect of the Vitreous in Response to Intravitreal (IV) Injections of Ranibizumab (0.5mg/0.05ml) for the Treatment of Diabetic Macular Edema
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEVITRA
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: