4 Week Dosing Beovu Study was Halted

Company halts a new BEOVU study, a drug for wet macular degeneration, as increased inflammation is noted.

A Beovu study was halted recently.

In a May 28, 2021 press release, Novartis Pharmaceuticals halted an ongoing trial of BEOVU (brolucizumab) for the treatment of wet macular degeneration. About 1 year ago, there were concerns over Beovu and potential complications.

BEOVU, an anti-VEGF drug, is FDA approved for the treatment of wet macular degeneration and is delivered via intraocular injection. The approval also allows for the drug to be repeated as often as every 8 weeks. The trial was to determine if Beovu could be administered every 4 weeks instead of 8. Most of the other anti-VEGF medications can be given every 4 weeks.

Other anti-VEGF medications include:

  • Lucentis (ranibizumab)
  • Avastin (bevacizumab)
  • Eylea (aflibercept)

All are given by intraocular injection and are powerful weapons for the treatment of macular degeneration, diabetic retinopathy and retinal vascular occlusions.

Why Study was Halted

This was originally a 2 year study where patients were treated every 4 weeks with Beovu. Great clinical studies are so-called “double blinded”, that is, neither patient nor treating physician knows what drugs are being delivered. This prevents bias in the study.

The results of the first year of the study were recently released which showed, when dosed at a higher frequency (4 weeks), an increase in the incidence of intraocular inflammation when compared to other studies.

The Beovu study was halted in the interests of patient safety. While most intraocular inflammation is well tolerated, that is, there is no long term sequalae, this conservative approach may save vision in many patients involved in the study as some patients may have permanently lost some vision.

This does not mean Beovu is not a good drug, it just means that studies indicate that the drug may have some toxicity if used too often. In the case of Beovu for macular degeneration, use every 4 weeks may be too often.

Presently the FDA has approved the drug to be used no more often than every 8 weeks.

Beovu Potential

Several studies have found that Beovu, when given only every 8 weeks, is a very potent and effective drug for wet macular degeneration, particularly in those patients where other drugs were unable to control the disease.

Ongoing clinical trials are testing the effectiveness of Beovu for treating diabetic macular edema (DME), a complication of diabetic retinopathy. Other anti-VEGF medications are also approved for the treatment of DME.

Retina specialists vary in their preference of anti-VEGF medications for certain conditions. Patient response to a particular medication often varies, for instance, consider the use of Tylenol, aspirin and ibuprofen. Though all can be used for pain relief, most of us find that one works better for us than the others.

It is very likely that Beovu will find it’s place in treating hard to treat patients with wet macular degeneration.

Stay tuned.

If you would like to schedule an appointment, please call us (877) 245.2020.

Nader Moinfar, M.D., M.P.H.
Retina Specialist
Orlando, FL

Lattice Degeneration

Many people are told they have “thinning of the retina,” but it’s real name is lattice degeneration and it could cause a retinal detachment.

Lattice degeneration is a fairly common, but abnormal, “thinning of the retina” that can cause a retinal detachment.  This type of degeneration affects the peripheral retina, and for reasons poorly understood, increases the chances of developing retinal tears or retinal holes that can lead to a retinal detachment

Lattice degeneration may be found in 8-10% of the population and seems to be found more frequently in families with this peripheral degeneration, myopia and a few rare diseases:

“Lattice” has characteristic findings, but only the presence of retinal holes is concerning.  Not all areas of lattice develop retinal holes.  When found, your retina specialist may feel treatment is necessary to prophylax against a retinal detachment.

Symptoms of Lattice Degeneration

There are no symptoms, but the condition may predispose you to retinal tears or retinal detachment, hence, patients should be on the lookout for symptoms of retinal tears or detachment including:

  • Flashes
  • Floaters
  • Blurred vision
  • Progressive loss of peripheral vision

Patients experiencing any of these symptoms should alert their eye doctor. 

Treatment of Lattice Degeneration

The majority of patients never require treatment and can be safely monitored.  There is absolutely no threat to the vision if a tear or retinal detachment do not ensue.  

The chance of developing a retinal detachment is quite small.  Still, it is recommended that patients with this peripheral thinning be monitored regularly.  Though progression is unlikely, retinal holes can develop over time.  Retinal holes develop slowly and gradually, whereas, a retinal tear can happen suddenly.

Retinal holes from lattice degeneration are treated and managed exactly the same way as treating a retinal tear.  Not all retinal holes from lattice degeneration require treatment. 

Laser treatment is the preferred treatment, however, cryotherapy and endolaser photocoagulation with vitrectomy are viable options as well.

In short…

In summary, lattice degeneration is usually a benign “thinning” of the retina that increases your chances of developing a retinal detachment over your lifetime.  Tell your doctor if you develop sudden flashes and/or floaters or if you experience loss of your peripheral vision. 

If you would like to schedule an appointment, please call us (877) 245.2020.

Nader Moinfar, M.D., M.P.H.
Retina Specialist
Orlando, FL

Treatment of Retinal Tears

Here are common ways a retina specialist can treat a retinal tear to prevent a retinal detachment.

Retinal tears can lead to a retinal detachment.  A retinal detachment can cause permanent vision loss and possible blindness.

Successful treatment of a retinal tear or retinal hole can prevent a retinal detachment from occurring. 

Posterior Vitreous Detachment

Also known as a PVD, a posterior vitreous detachment is the most common cause of a retinal tear.  The most common symptoms of a PVD are sudden flashes and floaters.

Any acute flashes or floaters require a complete dilated examination of the retina looking specifically for a retinal tear.  

Retinal Holes

Retinal holes are usually not caused by a posterior vitreous detachment, trauma or other eye surgery.  Most retinal tears are associated/caused by lattice degeneration, a common “normal” finding in many near-sighted patients. 

For the purposes of this article, both retinal tears and retinal holes are treated using the same techniques. 

Laser Treatment for Retinal Tears

The preferred treatment of a retinal tear is with laser treatment.  Laser light is used to create scarring around the retinal tear to prevent fluid from migrating underneath the retina.  This does not really fix the retinal tear, but it does prevent a retinal detachment from occurring. 

Laser treatment can be performed easily in the office setting and usually does not require any aftercare.  Most retinal specialists will recheck the retina a few weeks after laser treatment. 

Laser treatment usually does not cause pain when applied.  There are no nerves in the retina, but there are some deeper nerves in certain locations of the eye that can cause “discomfort.”

Cryotherapy for Retinal Tears

Not all tears can be treated with the laser.  Cryotherapy, an older treatment, can be equally effective.

For laser treatment to succeed, your retinal specialist must be able to see the entire retinal tear.  Some tears can not be completely visualized due to:

  • Vitreous hemorrhage (blood)
  • Cataract
  • Anterior location (hard to “see” the entire retina without special techniques/instruments)
  • Intraocular implants

Cryotherapy treats retinal tears by freezing them from the outside of the eye.  Because cryotherapy requires manipulation and indentation of the eye, more tears can be treated that otherwise could not be fixed with laser. 

Vitrectomy

As a last resort, intraocular surgery called vitrectomy can be used to treat a retinal tear.  In this situation, a laser probe is introduced inside the eye at the time of surgery to treat the tear.  Using the endolaser, the tear or hole is treated from the inside of the eye.  While virtually any tear can be treated in this fashion, it does require an invasive procedure and must be performed in the operating room. 

Regardless of the modality of treatment, the results are the same.  The goal is to prevent retinal detachments from occurring. 

If you would like to schedule an appointment, please call us (877) 245.2020.

Nader Moinfar, M.D., M.P.H.
Retina Specialist
Orlando, FL

Eye Injuries

Doing fireworks with my kids last night, reminded me that the forth of July is one of the most common holidays for eye injuries.
Patients can frequently receive burns to the cornea from sparklers. These burns, sometimes also called abrasions, are very painful. The cornea is one of the most highly innervated tissues in the body, and very sensitive to any injury. If the abrasion is small, simple lubrication may be all that is necessary. If larger, then sometimes the cornea may need to be patched.
Not infrequently, a piece of rust or debris may also get embedded in the cornea. In most cases, these pieces lie deeper than they appear, and need to be removed in the doctor’s office.
I’ve operated on several patients who have received an explosive blast injury to the eye, from a bottle rocket, or a fire cracker. In these cases, the eye (also called the globe) is torn open, and the injury is referred to as a ruptured globe; you can read more about ruptured globes under the trauma section of this web site. These injuries tend to be relatively complicated, because the eye becomes very disorganized, and it can be difficult to suture all the pieces back together. Not infrequently, such a patient will need the care of a retina specialist to fix associated problems, like a hemorrhage in the eye, retinal detachment, or foreign body.
Fortunately, most firework-related injuries are preventable. Keeping young children a safe distance from the excitement, and handlers wearing protective eye wear, can help everyone enjoy the festivities with peace of mind.

Vitrectomy for Vitreous Hemorrhage

As you have probably noticed from the videos on NaderMoinfarMD.com, a vitrectomy is a procedure that is used to address many different problems of the back of the eye.
With various modifications, a vitrectomy can be used to treat a retinal detachment, macular pucker/membrane, macular hole, and bleeding inside of the eye– also referred to as a vitreous hemorrhage,
A vitreous hemorrhage implies that the back portion of the eye contains free floating blood. Many conditions can cause a vitreous hemorrhage, but perhaps the most common is diabetes.
Diabetes can affect the eyes in a number of different ways, but more advanced stages, referred to as proliferative diabetic retinopathy, are more prone to cause visual problems. In this condition, abnormal blood vessels start to grow or “proliferate” on the surface of the retina; these vessels are abnormal, very fragile, and bleed easily.
If the bleeding is mild, then a trained retina specialist may elect to perform laser surgery in the office, if not already done.
Sometimes, a retina specialist may also choose to inject various medications into the eye, that can slow, or halt, the proliferation of new blood vessels.
If the blood doesn’t clear, then the option of removing it with vitrectomy surgery can be entertained.
As you can see from the videos on NadrMoinfarMD.com, the set up for this procedure is very familiar. The goals are to safely remove the blood, treat and remove any scar tissue, any apply laser treatment.
As with any other vitrectomy, the patient receives some mild sedative, and an anesthetic injection around the eye.
The area around the eye is then cleansed, and sterile drapes are placed around the eye.
The remaining steps are demonstrated for you on NaderMoinfarMD.com, under the “videos” pull-down menu: three cannulas are secured into the eye, the blood is removed, the vitreous is meticulously cleared, and laser is applied.
A patch is applied on the eye, and patients usually go home 30 minutes or so, after surgery.

Macular Hole Surgery

The treatment of a macular hole involves several steps.
as with all vitrectomies, the first step is to set up three ports, allowing for the insertion of an infusion cannula, and various instruments. These initial steps are shown under the “videos” section of NaderMoinfarMD.com.
After the jelly portion of the eye, called the vitreous, is removed, steroids are sometimes used in the eye to help identify and remove any remaining pieces of the vitreous; this step can also be seen under the videos section of this website.
In order to maximize the success of closing the macular hole, many surgeons, including myself, will use a green dye to help stain a very fine and delicate tissue, called the internal limiting membrane; removal of this tissue is believed to improve the chances of surgical success.
As you can see from my video, once the tissue is stained, it can be very delicately lifted and peeled using forceps. Sometimes, the tissue can be rather sticky, so great care is often needed to prevent injury.
Once this is completed, the eye is then filled with gas, which is helps provide a surface along where the edges of the hole can come together. I usually ask patients to try to keep their face down whenever they can, for about five days.
In almost all cases, macular hole surgery is done with the patient only lightly sedated, and the eye is made comfortable with the use of local anesthetics. This surgery is done as an outpatient, meaning that the patient does not have to remain in the hospital. In most cases, the patient will usually be on their way back home within an hour after the surgery is completed.
You will probably see a lot of different recommendations on face down positioning after macular hole surgery, and this is a frequent source of confusion, and concern, for patients. Unfortunately, there are no clear set standard as to how long, if at all, face down positioning is necessary. Some surgeons don’t advise any at all, while some advise for up to two weeks. In my experience, this extreme is neither necessary, practical, or beneficial. All I ask is that a patient do the best that they can, for about three to five days; I ask that they try to keep their face down for as long as they can, then take a break for as long they feel is necessary to recharge themselves. In most cases, this is more than enough. Ultimately, the key is mindful surgery, by a caring and competent surgeon

Jon Doe