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More innovation needed to deliver anti-VEGF treatment to AMD patients
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Patient compliance, or lack thereof, is a well-known issue that all ophthalmologists deal with every day. Studies, especially in the glaucoma literature, confirm that compliance decreases as the number of different drops required increases past one and the number of drops per drug increases past two.
The best compliance is with one drop once a day, and even then many patients miss drops for days and/or do not take their drops properly — for example, neglecting to shake suspensions adequately to assure a good mix of drug into the vehicle, close their eyes for at least 30 seconds after administration to enhance absorption or wait at least 5 minutes between drops when using more than one.
Now we have two more types of compliance risk to consider when treating a patient: family compliance and doctor compliance. Until the advent of anti-VEGF therapy for wet age-related macular degeneration, we did not have many treatment regimens that required a patient to return to the ophthalmologist every month for many years, perhaps a lifetime. Even patients with significant glaucoma were usually seen only every 3 months, and those with infections, while in some cases requiring daily visits, might only need to comply with frequent visits for a week or two.
The prospective clinical trials that established the efficacy of intravitreal anti-VEGF injections for wet AMD required monthly injections for 2 years. This regimen demonstrated a significant benefit in multiple studies, and compliance was good. However, the setting of such a clinical trial is different from real-world therapy.
In trials, treating doctors and their staffs are heavily incentivized and closely monitored to assure protocol adherence. Patients and their families know that compliance with recommended visits will not only affect their ocular health, but also the success of the study and the possible approval of a drug that might help millions worldwide. In addition, the treatment is not only free, but usually the patient is paid for his time. The bottom line: Poor compliance outside a severe health issue or death is just not allowed.
Now enter the real world of clinical medicine. The patient with wet AMD is old, usually suffering from many other health problems including, in many, some level of senile dementia or, at a minimum, memory loss. He is visually handicapped and must have a family member, usually younger and gainfully employed, bring him to the doctor. A decade of taking 1 day a month off work to drive to the nursing home to pick up a senior family member, transport him to the doctor, wait for the exams and treatment, and then return the patient to his care facility is simply not possible for many families without jeopardizing their jobs and financial well-being.
Even if the family or perhaps a friend is committed, many days the senior might be ill or just not feel like going for another examination and shot in his eye, which now costs him significant money every time even when insured. The cost in time and money for a patient and his family to support a lifetime of monthly visits, tests and drug injections for wet AMD is simply more than many can manage.
It makes sense that treat-and-extend regimens that reduce injection frequencies should be helpful, but it appears monthly examination visits may still be needed for best outcomes, even if injections can be less frequent. And it seems the whole experience may also be more than many treating ophthalmologists or the care systems in which they work can sustain.
Minnesota is a rural state, and for many outstate patients, the long travel to a retina specialist every month approaches the impossible. We now have a wonderful treatment for a blinding disease that is performed by the physician, so we do not have to rely on the patient to take the medicine or drop properly, but we still need to rely on the patient and his family to travel to the clinic monthly for years to undergo an expensive, time-consuming and somewhat painful treatment. I have had tearful patients tell me they and their families just cannot do it, even though they know the consequence may be significant loss of vision.
We must also realize there is increasing stress on the doctors and the systems that are struggling to deal with the significant demands of the treatment regimens recommended. Thus, significant social issues are negatively affecting the potential of a vision-saving and life-changing treatment.
The solution will require one or more innovations, either in the method of drug delivery through some form of sustained-release model requiring less frequent visits or perhaps an innovation in our system of care delivery by using telehealth and some form of care extender who may have to travel to the patient to examine and treat him under the supervision of a distant specialist.
As is so often the case, one form of innovation leads us to the need for another. Hopefully, the innovation cycle will work its magic to the benefit of our patients once again.