Diabetic Retinopathy
Conditions
Keywords
diabetic retinopathy, bevacizumab, photocoagulation
Brief summary
The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.
Detailed description
The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.
Interventions
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* symmetric proliferative diabetic retinopathy without high risk characteristics * age 18 years or older * patient consent
Exclusion criteria
* heart attack or cerebrovascular attack * only eye * retinal detachment * vitreous haemorrhage * previous treatment for diabetic retinopathy * media opacities that preclude visualization of the fundus * pregnancy * inability to understands the implications of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity at six months and one year | — |
| Macular thickness measured by OCT at six months and one year | — |
| Median deviation in visual fields at one year | — |
| Score on a patient satisfaction scale at six months and one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications associated to each treatment | — |
Countries
Mexico
Outcome results
None listed