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Single or Combined Protocols for NV-AMD

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ClinicalTrials.gov Identifier: NCT03552770
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Regione Emilia-Romagna
Information provided by (Responsible Party):
Francesco Parmeggiani, University Hospital of Ferrara

Brief Summary:
The present interventional study represents a Research Program for the Clinical Governance supported by supported by the Healthcare Fund of the Emilia-Romagna Region. It aims to evaluate, after 12 months of monitoring, clinical safety, therapeutic efficacy, number of intra-vitreous injections of bevacizumab (IVIB), compliance and quality of life correlated to the vision by comparing the data obtained in two groups of patients (group A and group B), affected by neovascular age-related macular degeneration (NV-AMD) never previously treated or already undergoing pro-re-nata (PRN) treatments with biological drugs inhibiting vascular endothelial growth factor (Vascular Endothelial Growth Factor, VEGF), i.e. anti-VEGF drugs. Participating patients are randomized to the following therapeutic regimens: i. group A, a single intra-vitreous injection of bevacizumab PRN repeated after monthly periodic monitoring of the patient (IVIBx1 regimen); ii. group B, two combined intra-vitreous injections of bevacizumab, spaced 30 ± 10 days apart and repeated as-needed after periodic monitoring of the patient (IVIBx2 regimen). Within the aforementioned regimens, the re-treatment (single or combined in patients undergoing IVIBx1 or IVIBx2, respectively) is performed when signs of persistent neovascular activity is present. The present trial consists of a randomized controlled open-label study with parallel arms to evaluate the non-inferiority of clinical safety and therapeutic efficacy of the IVIBx1 regimen compared to the IVIBx2 regimen (1: 1 allocation) administered in patients with NV-AMD. The number and type of tests, as well as the number of intra-vitreous injections of anti-VEGF drug performed in patients treated with the PRN regimens IVIBx1 or IVIBx2 do not differ from those performed during normal clinical practice at the Eye Clinic of the University Hospital of Ferrara. The intra-vitreous administration of bevacizumab is performed in accordance with the guidelines of the Italian Ophthalmology Society.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Bevacizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The enrolled patients are randomized to the following therapeutic regimens: i. group A, a single intra-vitreous injection of bevacizumab pro-re-nata repeated after monthly periodic monitoring of the patient (IVIBx1 regimen); ii. group B, two combined intra-vitreous injections of bevacizumab, spaced 30 ± 10 days apart and pro-re-nata repeated after periodic monitoring of the patient (IVIBx2 regimen).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Single or Combined Protocols for the Treatment of Patients With Neovascular Age-related Macular Degeneration: Compliance, Risk/Benefit and Cost/Benefit Ratios
Actual Study Start Date : November 23, 2014
Actual Primary Completion Date : November 24, 2016
Actual Study Completion Date : December 29, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: IVIBx1
Patients treated with a single intra-vitreous injection of bevacizumab (1.25 mg in 0.05 ml of solution) pro-re-nata repeated after monthly periodic monitoring of each patient
Drug: Bevacizumab
pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab
Other Name: intra-vitreous injection of bevacizumab

Active Comparator: IVIBx2
Patients treated with two combined intra-vitreous injections of bevacizumab, (1.25 mg in 0.05 ml of solution) spaced 30 ± 10 days apart and pro-re-nata repeated after periodic monitoring of each patient
Drug: Bevacizumab
pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab
Other Name: intra-vitreous injection of bevacizumab




Primary Outcome Measures :
  1. comparison of the mean modifications of the maximal visual acuity (BCVA, Best-Corrected Visual Acuity) between the IVIBx1 study group with respect to those registered in the IVIBx2 one [ Time Frame: 12 months ]
    verify the "non-inferiority" of the therapeutic efficacy of the IVIBx2 regimen versus IVIBx1 regimen, considering the mean modification of the maximal visual acuity (BCVA, Best-Corrected Visual Acuity)

  2. comparison of the number of intra-vitreous injections of bevacizumab (IVIB) between the IVIBx1 study group with respect to those performed in the IVIBx2 one [ Time Frame: 12 months ]
    verify the "non-inferiority" of the therapeutic responsiveness of the IVIBx2 regimen versus IVIBx1 regimen, considering the number of intra-vitreous injections of bevacizumab (IVIB)

  3. comparison of the number of non-severe adverse events (NSAE) between the IVIBx1 study group with respect to those registered in the IVIBx2 one [ Time Frame: 12 months ]
    verify the "non-inferiority" of the tolerability of the IVIBx2 regimen versus IVIBx1 regimen, considering the number of non-severe adverse events (NSAE)

  4. comparison of the number of severe adverse events (SAE) between the IVIBx1 study group with respect to those registered in the IVIBx2 one [ Time Frame: 12 months ]
    verify the "non-inferiority" of the safety of the IVIBx2 regimen versus IVIBx1 regimen, considering the number of severe adverse events (SAE)


Secondary Outcome Measures :
  1. comparison of the number of unjustified absences of patients at the diagnostic checks and/or therapeutic procedures between the IVIBx1 study group with respect to those registered in the IVIBx2 one [ Time Frame: 12 months ]
    verify the "non-inferiority" of the objective patient's compliance during the IVIBx2 regimen versus IVIBx1 regimen, considering the number of unjustified absences of patients at the diagnostic checks and/or therapeutic procedures foreseen by the study

  2. comparison of the mean modifications of the score of the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ) between the IVIBx1 study group with respect to those registered in the IVIBx2 one [ Time Frame: 12 months ]
    verify the "non-inferiority" of the vision-related quality of life during the IVIBx2 regimen versus IVIBx1 regimen, considering the mean modification of the score of the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ)

  3. comparison of the mean modification of the score of a specific questionnaire about patient's satisfaction for the received care between the IVIBx1 study group with respect to those registered in the IVIBx2 one [ Time Frame: 12 months ]
    verify the "non-inferiority" of the subjective patient's compliance during the IVIBx2 regimen versus IVIBx1 regimen, considering the mean modification of the score of a specific questionnaire about the assessment of patient satisfaction with respect to the received healthcare



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 50 years
  • ability to comply with study procedures
  • active NV-AMD in either treatment-naïve or previously treated patients
  • BCVA > 20/200 in the study eye

Exclusion Criteria:

  • any other possible cause of choroidal neovascularization other than AMD
  • ocular media opacities or other causes counteracting data collection
  • presence or onset of contraindications to the use of bevacizumab

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Responsible Party: Francesco Parmeggiani, Medical Doctor - Associate Professor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03552770     History of Changes
Other Study ID Numbers: PRUA2-2013-00002008
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Parmeggiani, University Hospital of Ferrara:
neovascular age-related macular degeneration
bevacizumab
pro-re-nata regimens
clinical governance
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors