Let me preface this by saying that I use off-label Avastin for various conditions (macular edema from vein occlusions, diabetes, wet AMD, and histoplasmosis). It is a great benefit to patients that are uninsured or underinsured. I always mention to patients the presence of Lucentis and the fact that much more is known about its safety and efficacy through randomized clinical trials. I usually finish with the statement: “I may be wrong, but my clinical impression is that both medicines (Avastin and Lucentis) work about the same.” After having said this about 1000 times, I began to think about other “clinical impressions” that physicians (ophthalmologists in particular) have had that were proven to be wrong by strong randomized clinical trials.
Optic nerve decompression for AION
Designed to evaluate whether optic nerve sheath decompression would benefit patients with nonarteritic AION, this trial began in October 1992 and was halted in October 1994. Patients in the treatment group were almost two times more likely to lose 3 or more lines of vision than in the observation group (23.9% vs 12.4%)1. In fact, the title of the JAMA paper is “Optic nerve sheath decompression surgery for NAION is not effective and may be harmful.”
MPS laser for choroidal neovascularization due to AMD (non-subfoveal)
There is a “must read” article that written by Stuart Fine, MD in which he recalls his experience with the initial MPS study. At the time, there was controversy about the benefits (and risks) of thermal laser treatment for choroidal neovascularization for AMD. The 18 month results of the study showed that 60% of untreated eyes and 25% of treated eyes lost 6 or more lines of vision. These results were not disclosed when Dr. Fine called each of the 16 MPS principle investigators to schedule a meeting to discuss the results. At the time, he asked each of the investigators if they felt the laser treatment was helpful. Fifteen of the 16 felt that it probably was not. This led Dr. Fine to say, “…even experienced clinicians can reach erroneous conclusions based on following a few dozen patients without an appropriate comparison group.”2
Oral steroids for optic neuritis
The Optic Neuritis Treatment Trial demonstrated a benefit to IV steroids (for 3 days) followed by oral steroids in speeding recovery of vision and improving the visual outcomes at 6 months. Another important finding of the ONTT was the fact that oral steroids alone was ineffective at treating optic neuritis and increases the risk of new episodes. This led the Optic Neuritis Study Group to recommend that oral steroids alone should be avoided.3
The past is littered with inaccurate assumptions based on “clinical impressions”. Hopefully the CATT trial will let us know the correct answer. For now, the only way you will be “wrong” is if you don't realize that you could be.
*Avastin use in ophthalmic diseases is off-label.
References:
1 Optic nerve decompression surgery for nonarteritic anterior ischemic optic neuropathy (NAION) is not effective and may be harmful. Ischemic Optic Neuropathy Decompression Trial Research Group. JAMA 1995; 273: 625-632.
2 Age-Related Macular Degeneration 1969–2004: A 35-Year Personal Perspective. SL Fine. Am J Ophthalmol 2005;139:405–420.
3 Randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med 1992; 326(9):581-588.
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