South San Francisco, CA — February 27th, 2016 — Protocol T Two-Year Results Published Today
The two-year results of the Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Comparative Effectiveness Protocol T Study were published today in Ophthalmology.
The study compared the efficacy and safety of Lucentis, aflibercept and bevacizumab to improve vision or visual acuity (VA) in people with diabetic macular edema (DME) based on the number of letters that are accurately seen on an eye chart. The primary study outcome, mean change in visual acuity at one year, was previously published in March 2015. (N Engl J Med 2015; 372:1193-1203 Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema.). A secondary and the final study endpoint at two years was chosen to determine if visual gains were sustained over two years, and whether there were differences in frequency of intravitreal injection or laser.
At year two, no statistically significant difference in mean change in visual acuity between Lucentis and aflibercept patients was observed in any pre-specified patient groups studied (overall, worse baseline vision (20/50 or worse) or better baseline vision (20/32 to 20/40)). The statistical difference observed at one year for aflibercept vs. Lucentis was no longer observed at year two with respect to the worse seeing group.
The median number of 15 injections given over the two years was the same for Lucentis and aflibercept.
The percentages of serious adverse events reported and of participants hospitalized within two years were similar across the three treatment groups. The data show an imbalance in Antiplatelet Trialists’ Collaboration (APTC) events for patients in the Lucentis arm. The study’s authors noted, "These findings have not been demonstrated consistently in previously reported clinical trials" and added, "the inconsistencies in the totality of the evidence create uncertainty as to whether there is a true increased risk of APTC events with ranibizumab at this time."
"These long-term outcomes are important when studying treatments for patients with a chronic disease like DME," said Jason Ehrlich, MD, PhD, Global Head of Ophthalmology Clinical Science at Genentech. "We are pleased that no statistical differences in vision outcomes or number of injections given at two years were seen when comparing Lucentis and aflibercept in all three pre-specified, Protocol T patient groups."
Based on the totality of evidence in support of its efficacy and well-characterized safety profile as well as the depth and breadth of clinical experience in treating complex retinal diseases, Lucentis continues to be an important treatment choice for physicians and patients.
The full study results can be found in the February 27, 2016 publication of Ophthalmology. Wells JA et al. for the Diabetic Retinopathy Clinical Research Network. “Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-year Results from a Comparative Effectiveness Randomized Clinical Trial.” Ophthalmology, February 27, 2016.
LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with diabetic macular edema (DME).
Diabetic Macular Edema (DME)
LUCENTIS 0.3 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days).
IMPORTANT SAFETY INFORMATION
LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS.
WARNINGS AND PRECAUTIONS
Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering LUCENTIS. Patients should be monitored following the injection to permit early treatment, should an infection occur.
Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with LUCENTIS. IOP and perfusion of the optic nerve head should be monitored and managed appropriately.
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
Fatal events occurred more frequently in DME patients treated monthly with LUCENTIS compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded.
Serious adverse events related to the injection procedure that occurred in <0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
In clinical trials in diabetic macular edema, the most common ocular side effects included conjunctival hemorrhage, cataract, increased IOP, and vitreous detachment. The most common non-ocular side effects included nasopharyngitis, anemia, and nausea.
For additional safety information, please see LUCENTIS full prescribing information at http://`www.LUCENTIS.com.
AVASTIN IMPORTANT SAFETY INFORMATION
Avastin is approved for:
Additional serious adverse events
In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group.
Patients who are pregnant, think they are pregnant, or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for six months following the last dose of Avastin. Avastin can cause fertility issues for women.
Women should be advised that breastfeeding while on Avastin is may harm the baby and is therefore not recommended.
Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin (exfoliative dermatitis).
Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555.
For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.
Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.