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This presentation aims to improve understanding of Lucentis and its role in treating visual impairment caused by diabetic macula oedema. It covers topics such as the mechanism of action, efficacy, safety, and practical guide to administering Lucentis.
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Dr Dan Bwonya Mengo Hospital, The Role of Lucentis in the treatment of Visual impairment due to Diabetic Macula Oedema
Objective of the Presentation • To improve our understanding on: • What is Lucentis (RANIBIZUMAB)? • What is Diabetic Macula Oedema (DME) • Mechanism of action of Lucentis on DME • Rationale for the use of Lucentis • Efficacy and safety of Lucentis • How to use Lucentis in clinical setting
What is Lucentis? • Humanised monoclonal antibody that binds to VEGF-A • Antibodies – • 5types, IgG is >75% • Monoclonal : • single clone, for specific antigen & produced from B cells in large quantities
Diabetic Macula Oedema • Pathological accumulation of fluid in the intra-retinal layers of the macula • Results from damage of BRB from VEGF • DME is leading cause of VI among Diabetic patients • If not treated > 50% will loss 12lines of VA in 2yrs
Rational for use of Lucentis • VEGF concentrations are Elevated in eyes with DME • VEGF disrupts BRB causing hyper permeability • Reverses some of the damage caused by the effect of excess VEGF
Mode of action of Lucentis • Binds and has high affinity for VEGF-A Isoforms (110,121,1650) • Prevents VEGF to bind to its VEGFR • Inhibits angiogenesis • Revervses some effects of VEGF over expresion
Efficacy and Safety of Lucentis • Registration Trials where Resolve and Restore RESOLVE trial • Compared safety and efficacy of 2 doses of Lucentis (0.3mg and 0.5mg) • Results: • Patients gained significantly more letters at 12 months with treatment Vs sham
Efficacy and Safety of Lucentis cct RESTORE study, • Compared efficacy and safety of Lucentis as adjunct therapy or monotherapy • Results: • Patients gained signifincantly more letters with Lucentis to either monotherapy or adjunct to laser therapy
Efficacy and Safety of Lucentis cct DRCR.net Protocal I trial • Demonstrated that Lucentis 0.5mg combined with prompt Laser or differed laser of DME provide rapid and sustained VA gain in 12M READ-2 study • Demonstrated 0.5mg Lucentis monotherapy or combined with laser Vs laser monotherapy showed rapid and sustained VA gain over 2yrs
Safety of Lucentis • Well tolerated in patients • Associated side effects • UTI, Cardiovascular and celebravascular accidents • Ocular side effect like: pain, redness, infection, cataract and raised IOP
Other studies about Lucentis • RESTORE extention • RISE • RIDE • REVEAL • RETAIN
Initiating treatment • Following diagnosis of DME • Give minimum of three treatment of Lucentis • Re-assess patient VA • Then modulate treatment accordingly
When to stop treatment • Decided on BCVA and Macula OCT • If 3 consecutive treatment given without VA gain
Practical guide in administering Lucentis • Dilate Pupil • Apply Topical anaesthesia • Clean per ocular skin and lids with 10% Povidone- Iodine • Drape patient • Apply sterile lid speculum • Instil 5% povidoni iodine • ophthalmicsolution and wait for 90 seconds • Rinse the eye with saline solution
Practical guide in administering Lucentis • Direct the patients to look away the injection site. • Mark an injection site at 3.5 – 4.00mm posterior to Limbus • Avoid horizontal meridian • Aim at the centre of the globe