High Risk Proliferative Diabetic Retinopathy
Conditions
Keywords
Diabetes, Proliferative Retinopathy, Ranibizumab, Panretinal Photocoagulation
Brief summary
This study is a prospective, randomized, multicentre, open label study that intents to compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy over a 12-month treatment period. One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of the leading causes of visual impairment in working age in industrialized countries. Longer diabetes duration and poor glycaemic and blood pressure control are strongly associated with Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4% and 6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately 93 million people have Diabetic Retinopathy and 17 million of them have Proliferative Diabetic Retinopathy. It has been shown that treatment with repeated injections of ranibizumab can improve visual acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete and, therefore, efforts should be done to understand and characterize patients' eyes response to combined treatments. Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e. Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV injections of ranibizumab since it is expected that anti-vascular endothelial growth factor (VEGF) treatment with ITV injections will increase the rate of success of Panretinal Photocoagulation in regression of neovascularization with improved final visual acuity.
Interventions
Sponsors
European Vision Institute Clinical Research Network
Association for Innovation and Biomedical Research on Light and Image
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
* High-risk proliferative diabetic retinopathy (HR-PDR); Neovascularization in the disc (NVD) ≥ 1/4 disc area (DA) OR Neovascularization elsewhere (NVE) ≥ 1/2 DA; NVE \< 1/2 DA + vitreous and/or pre-retinal haemorrhage and/or rubeosis; NVD \<1/4 DA + vitreous and/or pre-retinal haemorrhage and/or rubeosis; * BCVA at baseline ≥ 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters score (approximate Snellen equivalent 20/320); * Type I or Type II diabetic subjects of either gender; * Age ≥ 18 years; * Ability to provide written informed consent; * Ability to return for all clinical trial visits;
Exclusion criteria
* Any intraocular surgery within 6 months before trial enrolment, including: Prior scatter (panretinal) or focal/grid photocoagulation; Eyes who have received yttrium aluminum garnet (YAG) laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only); * Fibrovascular proliferation with retinal traction; * Other cause of retinal NV (retinal vein occlusion, radiation retinopathy or others); * Atrophy/scarring/fibrosis/ hard exudates involving the centre of the macula; * Significant media opacities or inadequate pupillary dilation, which might interfere with visual acuity, assessment of toxicity or fundus photography; * Any likelihood that the subject will require cataract surgery within the following 1 year; * Diabetic macular edema (DME) with central involvement, i.e., central macular thickness (Central Point Thickness) \> 300 µm (Stratus OCT) equivalent values measured by spectral domain (SD)-OCT, adjusted according to the SD-OCT machine used; * Previous vitrectomy; * Intraocular pressure \> 21 mmHg; * Previous anti-VEGF therapy within the last 3 months; * Known serious allergies or history of hypersensitivity to fluorescein used in angiography, or to components of Lucentis® formulation; * Acute ocular or periocular infection; * Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage device (e.g., tube-shunt surgery); General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression of neovascularization | 12-month treatment | Defined as any decrease in the area of neovascularization |
Secondary
| Measure | Time frame |
|---|---|
| Time to complete neovascularization regression | 12-Month treatment |
| Recurrence of neovascularization | 12-Month treatment |
| Macular retinal thickness | 12-Month treatment |
| Changes in Best Corrected Visual Acuity (BCVA) | 12-Month treatment |
| Need of vitrectomy due to the occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of Diabetic Retinopathy. | 12-Month treatment |
| Adverse events related to the treatments | 12-Month treatment |
| Need of treatment for Diabetic Macular Edema | 12-Month treatment |
Countries
France, Italy, Portugal, United Kingdom
Outcome results
None listed