- Diabetic Macular Edema
This drug was approved by the FDA in June 2006 for the treatment of wet AMD. The below graph shows the average visual acuity change of patients treated with Lucentis v. those not treated with Lucentis. As you can see, the Lucentis prevents vision loss and is the first treatment for wet macular degeneration ever to IMPROVE vision.
The treatment as given in the patients recorded in the above graph requires an intravitreal injection monthly. Some recent studies have shown benefit with treatments monthly initially and then examination monthly and retreatment as needed. With these treatments patients require injections 6 times a year.
Lucentis is very expensive. The drug costs a little over 2000 dollars per treatment. If a patient is treated monthly this is about 24000 dollars per year. Some insurace companies require patients to pay 20% or 30% of the cost of the drug each time it is used. This is usually about 400 dollars to 700 dollars per month. Because of the high cost, alternative treatments like Avastin have been adopted in some situations.
Lucentis for Diabetic Macular Edema Results of 2 Pivitol Studies
Ranibizumab for Diabetic Macular Edema: Results from 2 Phase III Randomized Trials: RISE and RIDE Quan Dong Nguyen, David M. Brown, Dennis M. Marcus, David S. Boyer, Sunil Patel, Leonard Feiner, Andrea Gibson, Judy Sy, Amy Chen Rundle, J. Jill Hopkins, Roman G. Rubio, Jason S. Ehrlich Ophthalmology 1 April 2012;789-801
Intravitreal injections are very effective treatments for diabetic macular edema. Intravitreal steroids and vascular endothelial growth factor inhibitors are both effective, in the short term, at reducing macular edema. The benefit of these treatments is there rapid effect at reducing swelling. Combining laser with injection therapy has been shown more effective in some studies than laser alone for macular edema involving the center of the fovea.
In BRAVO, 61% of LUCENTIS patients gained ≥15 letters at month 6:
This study compared monthly injections with Lucentis to monthly sham (placebo) treatments. The patients treated with Lucentis did much better than those treated without Lucentis.
In BRAVO, 0.8% of LUCENTIS patients had BCVA ≤20/200 at month 6 versus 9.1% with sham (P<0.01).
48% of LUCENTIS patients gained ≥15 letters at month 6:
- On average, patients treated with LUCENTIS experienced VA gains throughout 6 months of treatment
- 1.5% of patients lost ≥15 letters with monthly LUCENTIS at 6 months versus 15.4% with sham
Brown DM, Campochiaro PA, Singh RP, et al; for the CRUISE Investigators. Ranibizumab for macular edema after central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117:1124-1133.