Prof. Ramin Tadayoni leads a discussion about the clinical management of patients with nAMD, DR, and ROP treated with ranibizumab.
In ROP, is there still room for laser treatment, and what is the maximum number of anti-VEGF injections that can be given?
Prof. Eter: In my practice I prefer not to apply laser treatment in ROP babies. However, if a clinician finds that anti-VEGF treatment is not enough, of course peripheral laser can be added if necessary. In terms of the number of anti-VEGF injections, usually one is enough, but according to the protocol there could be two repeat injections.
In light of the recent approval of ranibizumab for ROP, what practical information can you provide on administering ranibizumab to ROP babies?
Prof. Eter: A different syringe is used to administer ranibizumab to babies compared with adult patients, and the dose is reduced. The injection is performed under general anesthesia, with RetCam (Natus Medical Incorporated) imaging performed before injection. If both eyes are affected, we perform bilateral injections in the same session. Follow-up occurs every 4 days. If treatment is effective, the results are usually apparent within a few days. However, if active disease remains, then another injection is given after about 3 to 4 weeks.
In nAMD, are there any studies showing a benefit of one anti-VEGF agent over another?
Prof. Schlottmann: If you look at the results of the VIEW 1 and 2 studies35 and those of RIVAL,7,8 we see no differences whatsoever regarding VA outcomes, number of injections, development of macular atrophy, safety, or any other major endpoint that you may want to look at. When I discuss this issue with colleagues who tell me that they have seen a difference in the clinic, I tell them that what is statistically significant in a clinical trial can be invisible in clinical practice, and what appears significant in individual clinical practice is often proved to be an anomaly in a large clinical trial.
What is your preferred regimen for treating a patient with nAMD with anti-VEGF therapy?
Prof. Schlottmann: My preferred regimen would be T&E, but it depends on the region the patient comes from since sometimes the payors will not reimburse treatment without an OCT image showing disease activity. That means I have to use a prn regimen in those patients.
Prof. Koh: T&E is also probably my favored regimen. However, not every patient needs such proactive treatment. I usually provide three initial injections if possible, then wait 2 months without treatment. If there is early recurrence of activity, the patient is immediately moved to T&E. If there is no disease recurrence, I give the patient the option of prn but with the proviso that they must be prepared to return every month for review. Most patients can’t or don’t wish to do this, so they choose T&E.
Prof. Eter: In cases of bilateral disease, we use prn, but if it’s just one eye that is being treated, then I prefer T&E.
In DR, are you concerned that injecting an anti-VEGF agent may lead to detachment of the macula?
Prof. Koh: I think there’s always a risk of acceleration of fibrosis and traction, so patients must be counselled appropriately. If anti-VEGF is given, it should be done in the knowledge that the macula may detach and that the patient might require vitrectomy. However, while I wouldn’t say that there is no risk, I do think the risk has been overstated. In the Protocol S study, for example, the rate of tractional retinal detachment was just 5%.21
Could combining anti-VEGF injections with PRP decrease the number of injections required to treat PDR?
Prof. Koh: The results of the PRIDE study suggest that there is no added advantage to combining PRP with anti-VEGF therapy.23,24 In addition, I think it’s wrong to assume that once PRP is done you never have to repeat it again. These patients must still be watched for recurrence of PDR in the future, in the same way that you cannot be complacent after treating PDR with anti-VEGF therapy and say that the disease is gone for good. However, if patients are unable to come back frequently for repeated injections, PRP could potentially be useful—it’s always good to have more than one option.
Conclusions: Ramin Tadayoni
In summary, ranibizumab has been proven to be an effective therapy for retinal diseases across all ages. In babies with retinopathy of prematurity, the RAINBOW study showed that infants treated with ranibizumab 0.2 mg were twice as likely to achieve treatment success versus those treated with laser. In patients of working age, ranibizumab treatment in DR is associated with a reduced risk of DR worsening in eyes with or without PDR. Finally, in older patients with nAMD, the RIVAL study demonstrated comparable clinical outcomes between ranibizumab 0.5 mg and aflibercept 2.0 mg in a T&E regimen. “The wealth of scientific evidence available for ranibizumab has led to seven approved indications and the flexibility in the product label to enable us to meet our patients’ needs, whatever their ages,” said Prof. Tadayoni.
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