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Aflibercept and Bevacizumab for Diabetic Maculopathies

ConditionDiabetic Maculopathy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorAl-Mustansiriyah University

About this trial

The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include:

* Functional changes: The visual outcomes achieved by testing visual acuity * Anatomical changes: macular thickness and edema by optical coherence tomography (OCT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with type 2 diabetes mellites.

Patients diagnosed with diabetic maculopathies, including focal and diffuse maculopathies, according to Early Treatment of Diabetic Retinopathy Study (ETDRS) criteria

Patients with reduced or reduced vision (6/9-6/90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm)

Patients will be treated with intravitreal anti-VEGF treatment, aflibercept, or bevacizumab for three successive monthly injections.

Disqualifiers

Patients with type 1 diabetes mellites

Patients with type 2 on insulin therapy.

Patients who were previously treated with intravitreal anti-VEGF within the previous three months or intravitreal corticosteroids for six months

Prior macular photocoagulation or photodynamic therapy, prior intraocular surgeries within three months (laser & surgery may cause edema)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bevacizumab Injection [Avastin]

    Drug

    1.25 mg intravitreal injection given once monthly for three consecutive months.

  • Aflibercept 2Mg/0.05Ml Inj,Oph

    Drug

    2.0 mg intravitreal injection given once monthly for three consecutive months.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Bevacizumab groupActive comparator 1 intervention
Group B: Aflibercept groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual accuty assessed by snellen chart

The visual outcomes achieved by testing visual acuity by snellen chart

Time frame
one day before start of treatment, and after 3 months of starting the treatment
2

Central fovial thinkness by OCT

Macular thickness by optical coherence tomography (OCT)

Time frame
one day before start of treatment, and after 3 months of starting the treatment

Secondary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Safety profile and adverse events reported Safety profile and adverse events reported with bevacizumab and aflibercept use and their association with changes in functioning changes.

Time frame
During the three months after starting the treatment till the end of follow-up.
2

Quality of life assessed by Visual Functioning Questionnaire 25 (ARB-VFQ-25)

Quality of life-related to visual functioning will be assessed using the Arabic version of the Visual Functioning Questionnaire 25 (ARB-VFQ-25). The ARB-VFQ-25 will be assessed and validated before the start of data collection.

Time frame
one day before start of treatment, and after 3 months of starting the treatment
3

Adherence assessed by Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT)

Assessment and validation of the Arabic version of the Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT) and studying the barriers to adherence that may affect intravitreal drug use.

Time frame
one day before start of treatment, and after 3 months of starting the treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Mustansiriyah University

Lead sponsor

Baghdad Medical City

Collaborator

Source ClinicalTrials.gov
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