How many anti-VEGF injections of Avastin or Lucentis are needed to treat wet macular degeneration? We don’t know. While there is no question that anti-VEGF injections are the gold-standard for the treatment of ARMD, the exact way in which they are used varies from doctor to doctor.
The standard of care for macular degeneration changed. The standard treatment for wet ARMD was Visudyne and before Visudyne, laser treatment.
Since Macugen, the initial anti-VEGF medication, other accepted standards have evolved including Lucentis and Avastin.
In the medical world, these are still “new” treatments and we are still finding our way. We are always looking to improve our treatments.
In short, FDA Approval is needed to get a new drug introduced to the market. To state another way, FDA approval is needed to make it legal for a company, in the United States, to sell a drug.
Once available on the market, however, the way in which the drug is utilized varies from doctor to doctor.
When a drug is initially sent to the FDA for approval, careful testing (clinical trials) must be completed proving safety and efficacy of the drug. The drug company must prove that it is safe in humans and that the drug does what the company claims it does.
For example, in the case of Macugen or Lucentis the treatment protocol used in the study (to prove the drug works) may have required injections every 6 weeks for more than a year. During these studies, there is strict adherence to the protocol. Little variation is allowed. For instance, every six weeks means every six weeks. If a patient were to receive an injection other than the 6 week interval, that patient may be removed from the study.
When first introduced, everyone (doctors) followed a very similar protocol. We followed the protocol that was recommended by the manufacturer. They can only recommend the protocol approved by the FDA. That protocol is usually the same one that was included in the original study series.
With time, doctors get familiar with the drug and gain experience using the drug. Real life situations are not as stringent as FDA studies. We may find that if Mr. “Macugen” missed an injection, he does okay anyway. We may find that Ms. Lucentis can’t get an injection in 6 weeks, but can come in at 5 weeks.
Other studies, not necessarily for FDA purposes, emerge from our academic colleagues that change protocols, too. Perhaps a study is published from Johns Hopkins purporting great results using injections every week. Guess what, it’ll change how we practice.
Studies of related products also change how we practice. For instance, the protocols used for studies involving any of the anti-VEGF medications impact the use of the other drugs.
What Does This Mean? Treatments vary from doctor to doctor. The better a treatment, the more variation…in my opinion. The best treatments are inherently really good and do not require strict methods of employment.
Like a good recipe, a good treatment is hard to mess up.