Macular Degeneration

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Evaluation of patients' experiences with conventional and alternative therapies at dry and wet macular degeneration. Includes success, risks, cost, addresses...


Macular Degeneration & Lucentis / Avastin / Macugen

A treatment with Lucentis, Avastin or Macugen can only be done exclusively at the wet form of macular degeneration. At the dry form of macular degeneration this therapy will not apply. The reason for this is that with the wet form of macular degeneration, an "unwanted vessel growth," takes place which is tried to be avoided with the injections.

The use of Lucentis, Avastin or Macugen should inhibit the release of the so-called VEGF (vascular endothelial growth factor) hormone. The aim is to block a certain form when using Macugen and when using Lucentis / Avastin all isoforms of VEGF.

The treatment of wet AMD with Lucentis or Avastin is to inhibit hormone release, which otherwise promote the unwanted vessel growth and the increased permeability of vessel walls.

Contact for this therapy:

None of the many clinics who do shots into the eye were named to us strikingly often. You should contact your local clinics and ask whether they offer this therapy and if not whether they know a clinic which does.

Macular Degeneration & Lucentis: Three health insurer pay for Lucentis treatment:

With date August 16, 2010 the Pharmazeutisch Zeitung online, reports that patients insured at DAK (Deutsche Angestellten Krankenkasse), TK (Techniker Krankenkasse and the Hanseatischen Ersatzkasse pay now the cost for a lucentis treatment. This was possible due to a discount agreement.

At the legal health insurer the treatment with Lucentis is still missing from their catalogue. Often a treatment with the cheaper Avastin, which is manufactured by Roche, is suggested. Avastin is legally not released in Germany for treating a macular degeneration.

We already reported about social court Aachen (see further below) which gave patients the right to be treated with the officially released medication Lucentis in its sentence of March 11, 2010.

Social court Aachen decides: Legally health insured with an eye disease must receive the original drug

Social court Aachen sentenced on March 11, 2010 that legally insured patients suffering from the wet form of macular degeneration had a right to be treated with the for this disease authorized medication Lucentis®. A reference to the cheaper but for the ophthalmic area not approved medication Avastin® was not allowed. Thus, Lucentis® is the only in Germany authorized medication for treating a wet macular degeneration.

Social court Aachen, sentence from March 11, 2010 - S 2 (15) KR 115/08 KN (not legally binding)

Macular Degeneration & Avastin: News 11/24/2009

In a today published press release it was declared that the cost authorization of the British Ministry of Health had rejected the drug Avastin as too expensive. According to the press release the cost checking office relates this statement on the treating of stomach cancer with Avastin. A statement with regards to macular degeneration and Avastin respectively macular degeneration and the much more expensive Lucentis remains to be seen.

Macular Degeneration & Avastin: Legal Issues

Since 2005, the drug Avastin is used against the problematic vessel growth in wet macular degeneration. To date, this drug has not been officially authorized for the treatment of macular degeneration. The manufacturer of Avastin, which is also the manufacturer of Lucentis, also plans to have Avastin not authorized for the field of ophthalmology. Due to the lack of authorization for the treatment of macular degeneration, official instructions are also missing on potential adverse effects of its use in the eye. Nevertheless, it appears the injecting of Avastin is a widely used conventional method for the treatment of wet macular degeneration.

Originally Avastin comes from the Cancer Research and for example, is often used against intestine cancer. In a tumor treatment, the drug Avastin is injected directly into a vein in your arm. Due to the propagation through the bloodstream, it often leads to side effects throughout the body. With the injection of Avastin into the by wet macular degeneration affected eye, the dose used is much lower and is therefore considered to have fewer side effects. The drug Avastin inhibits angiogenesis on the one hand and seals on the other vessels, hence the use in wet macular degeneration. It is an antibody with the drug Bevacizumab, which blocks vessel-building, also called VEGF-Hormone (VEGF: Vascular Endothelial Growth Factor) and thus preventing the blood supply of tumors.

The goal, therefore, is a lower release of VEGF hormone. .

It was found out that Avastin also is able to block and seal the abnormal growth of vessels as well as leaking vessels over this mechanism in a wet macular degeneration. At best, it seems possible to transform a wet macular degeneration back into a dry macular degeneration and thereby prevent the normally serious vision loss through the abnormal vessel growth with a wet macular degeneration.

A so-called off-label therapy, so a drug that can also help with other diseases than those for which it was approved, is allowed in Germany, unless another approved method for this area is available. Since the approval of Macugen and Lucentis, therefore, a certain legal problem lies in the use of Avastin for a wet macular degeneration. Ophthalmologists who inject Avastin into the eye at a wet macular degeneration are moving therefore in a legal gray area.
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Macular Degeneration & Lucentis / Avastin / Macugen: Implementation of injections

The drug is intravitreally, i.e. directly into the back of the eye (vitreous body) injected. This takes place in the so-called Pars Plana, about 4 mm from the edge of the cornea. Those intravitreal injections are used in ophthalmology in order to bring high drug concentrations at the location directly. This approach aims to also reach a as low drug concentrations in the rest of the body as possible, in order to reduce possible side effects outside of the eye. Since the effect in the vitreous and retina lessens over time by natural degradation, a repeated injection every 4 (Lucentis, Avastin) to 6 (Macugen) weeks is necessary to ensure a continuous effect on the pathological vessel growth in wet macular degeneration. The injections are ambulatory and done under local anesthesia (drip anesthesia) and should be mostly painless. According to Pfizer, the therapy lasts for wet Macular Degeneration 1-2 years. Currently, initially three injections are given in a monthly interval and then a decision is made whether more are needed. In most cases, it is to be expected that the treatment at a wet macular degeneration has to be carried out continuously, since there is a tendency to a renewed "undesirable" vessel growth (as is also the experience with PDT). It also shows that the cause (poor metabolism, blood flow in the macular, etc.), ie the dry macular degeneration is persistent.
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Macular Degeneration & Avastin / Lucentis: Risks

Despite sterile precautions the patient must be observed continuously during surgery as it can possibly lead to an increase in intraocular pressure.

The following complications are also known:
  • Retinal detachment with the risk of total blindness
  • Occlusions
  • Irritation of the eyes
  • Bacterial infections
  • Infectious inflammation caused by fungi or viruses
  • Reddened conjunctiva
  • Severe pain

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Macular Degeneration & Avastin / Lucentis / Macugen: Achievements

The improvement of vision in a wet macular degeneration is seen as a big success. This means, for example, that if viewing "less crooked lines" at the Amsler test or the big spot in the middle of the visionary field becomes smaller and thus the patient is able to better see. The aim of most studies is to achieve a "stabilizing" effect. In the "study language" "improvement" is seen often only as a slowing of the normally without treatment continuing loss of visual acuity in macular degeneration. Therefore, the success to the effectiveness of various drugs in the treatment of wet macular degeneration, which is circulating in the media can be seen as critical since is is often based on the study perspective.

In the best case, if no risks and side effects occur, the said vessel growth inhibitor can transform a wet to a dry macular degeneration. Of course, in the course of treating macular edema disappear and thus the by that caused distortion and vision loss. Nevertheless, the dry form of macular degeneration maintains and hence the tendency to progressive visual loss.

According to doctors about 20% of all patients with wet macular degeneration cannot be helped. The most common reason is that the disease macular degeneration has already progressed too far (scars in the retinal center). According to manufacturer the injections have to be repeated every 4 to 6 weeks for the duration of about one to two years.
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Makuladegeneraton & Avastin / Lucentis: Authorization

Avastin, is said in the trade press, to be now the world health standard.

The same company that makes Avastin has also introduced a new drug for treating the wet macular degeneration for the German market in late January 2007. The newer drug called Lucentis contains the active ingredient Ranibizumab, but inhibits vascular growth in macular degeneration in the same way as Avastin. It is a modified cleavage product of Avastin. Clinical studies, it is said, could prove, however, that Lucentis and Avastin for macular degeneration contribute equally well. However, Lucentis was specifically tested for the treatment of macular degeneration and officially authorized. An authorization for Avastin for the use in wet macular degeneration is not planned by the manufacturer.
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Macular Degeneration & Lucentis: Side Effects

The manufacturer of Lucentis reported about the following side effects of this drug in treating macular degeneration (also associated with the injection procedure).

Side Effects: Serious adverse events were associated with the injection process and which occurred at <0.1% of intravitreal injections were endophthalmitis, rhegmatogenous retinal detachment. Partial tear of the retina and iatrogenic traumatic cataract.

Adverse effects occurred in controlled studies more frequently in Lucentis-treated patients with macular degeneration than in the control group:

Very common: conjunctival hemorrhage, eye pain, ...and another 59 side effects (very frequent, frequent and occasional) of Lucentis injections for wet macular degeneration.
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Macular Degeneration & Avastin / Lucentis: Cost

Treatment with Lucentis costs about € 1.600, - per injection. An Avastin treatment costs about € 40, - per injection. The newer drug to treat macular degeneration with almost the same active substance is 40 times more expensive.

It has been calculated in order to treat all patients with macular degeneration in Germany with Avastin the health insurer would have to about 100 million €. However, to treat the same number of patients with Macular Degeneration with Lucentis about three billion Euros would be needed. This represents about one-eighth of the entire German pharmaceutical budget.

In the U.S., the U.S. company Genentech said in October 2007 in a letter to all ophthalmologists in the U.S., that they could no longer order Avastin from December on. The manufacturer would like you to apply only the drug Lucentis for the treatment of macular degeneration.
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Macular Degeneration & Avastin / Lucentis: Particular Side Effects

According to reports side effects have to become known which could question the use of Avastin and Lucentis at macular degeneration. Shortly after Lucentis was approved in Germany for treating macular degeneration (late January 2007), studies from the United States told of dramatic side effects. In the United States Lucentis has been used against macular degeneration for quite some time.

There was a study with 5,000 by macular degeneration affected, in which not only the efficacy of Lucentis in macular degeneration, but especially the side effects and safe use of Lucentis should be explored.

Six months after the study had begun it showed that in the treatment of macular degeneration with Lucentis, with correct dosage, the risk of suffering a stroke was obviously four times heightened.

Whether the risk of a prolonged use of Lucentis for macular degeneration may possibly even increase was not yet known. In the press it was said that eye doctors had already suspected the likes, since the active agents of Lucentis and Avastin not only selectively inhibit angiogenesis in the eye with macular degeneration, but throughout the body of the by macular degeneration affected patients. Of particular concern is Lucentis and Avastin, therefore, in view of the fact that most sufferers of macular degeneration have already reached an age in which they often have long been suffering from cardiovascular ailments.
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Macular Degeneration & Macugen: In General

The drug Macugen was authorized in February 2006 in Germany for the treatment of wet macular degeneration. It is like Avastin and Lucentis injected directly into the vitreous cavity of the eye which is affected by macular degeneration. On the web site of Pfizer, the current German manufacturer of Macugen it is reported that Macugen needs to be injected into the eye every 6 weeks, thus nine times per year.
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Macular Degeneration & Macugen: Side Effects

About Macugen, or in connection with the injection process, the following side effects are known in the treatment of wet macular degeneration:

Adverse Reactions: The following data is a summary of all potentially on the procedure and medication related adverse events in the 295 patients in the treatment group that was treated in controlled studies with 0.3 mg.

Eye diseases according to frequency: The following ocular adverse reactions were assumed to be of a possible causal relationship related to a treatment with Macugen (either with the injection procedure or Macugen). In most cases, these side effects have been attributed to the injection procedure.

Very common: inflammation of the anterior chamber of the eye, eye pain, ...and 94 other side effects (very frequent, frequent and occasional) in jections of Macugen for wet macular degeneration..

Experience after introduction to the market: Rare cases of anaphylaxis / anaphylactoid reactions, including angioedema have been reported in patients who received Pegaptanib combined with other drugs during the preparation for the injection.

Please also note the circular.
As of: January 2006

In case of any irregularities that might indicate complications you should notify your doctor as soon as possible.
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Side effects of Lucentis injections for macular degeneration

Very common: :
  • Hemorrhage in the retina
  • Vitreous detachment
  • Intraocular inflammation (inflammation of the eyes)
  • Impaired vision
  • Conjunctival hemorrhage
  • Increase of intraocular pressure
  • Eye pain
  • "Floaters" (Mouches volantes)
  • Eye irritation
  • Cataract
  • Foreign body sensation in eye
  • Blepharitis
  • Subretinal fibrosis
  • Ocular hyperemia
  • Deterioation of vision (incl. blurred seeing)
  • dry eye
  • Vitritis
  • Headache
Common:
  • Maculopathy (damage to the macular)
  • Detachment of the retinal pigment epithelium (the layer that is responsible for the removal of metabolic end products.)
  • Opakification the refracting media (clouding of eye lens or vitreous)
  • Eye problems
  • Hyperemia of the conjunctiva
  • Retinal exudation
  • Local reactions at the injection site
  • Lacrimation increased
  • Itching of the eyes
  • Conjunctivitis
  • Nausea
  • Arthralgia
  • Back pain
  • Bronchitis
  • Anemia
Uncommon:
  • Retinal Degeneration
  • Functional disorders of the retina and vitreous
  • Bleeding in the eye
  • Blindness
  • Vitreous hemorrhage
  • Iritis
  • Iridocyclitis
  • Keratitis punctata
  • Keratopathy
  • Dents and streaks (striae) of the cornea
  • Light Sensitivity
  • Nuclear cataract
  • Irritation of the anterior chamber
  • Cornea abrasion
  • Narrow-angle glaucoma
  • Uveitis
  • Endophthalmitis
  • Retinal detachment
  • Retinal tear
  • Eyelid edema
  • Irritation of the eyelid
  • Corneal edema
  • Hypopyon
  • Atrial fibrillation
  • Coughing
  • Gasping
  • Increased secretion of the upper airways
  • Lichenoid keratosis
  • Arterial thromboembolic events (2.5%)
As of January 2007

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Nebenwirkungen zu Macugen-Injektionen bei Makuladegeneration

Sehr häufig:
  • Augenschmerzen
  • erhöhter Augeninnendruck
  • Entzündung der vorderen Augenkammer
  • Keratitis punctata
  • Mouches volantes und Glaskörpertrübungen
Häufig:
  • Augenausfluss
  • Augenbeschwerden
  • Augenentzündung
  • Augenjucken
  • Augenlidödeme
  • Augenreizung
  • Augenrötung
  • Augenschwellung
  • Bindehautblutung
  • Bindehauthyperämie
  • Bindehautödem
  • Defekt des Honhautepithels
  • Endophthalmitis
  • Fehlempfindung im Auge
  • Glaskörperablösung und -funktionsstörung
  • Grauer Star
  • Hornhautödem
  • Hornhautdystrophie
  • Konjunktivitis
  • Netzhautblutungen
  • okuläre Hypertension
  • Makuladegeneration
  • Mydriasis
  • periobitale Hämatome
  • Photophobie
  • Photopsie
  • Sehstörungen
  • Störung des Hornhautepithels
  • trockene Augen
  • verschwommenes Sehen
  • verringerte Sehschärfe
  • verstärkte Tränensekretion
Gelegentlich:
  • allergische Konjuktivitis
  • Asthenopie
  • Augenablagerungen
  • Augenblutungen
  • Augenlidreizung
  • Bläschen an der Injektionsstelle
  • Blepharitis
  • Chalazion
  • Deformierung der Pupillen
  • Ektropium
  • Erkrankung der Hornhaut
  • gestörte Pulillenreflexe
  • Glaskörperblutung
  • herabgesetzter Augeninnendruck
  • Hornhautablagerungen
  • Hornhautabschürfung
  • Hornhauterosion
  • Hyphämie
  • Iriserkrankung
  • Iritis
  • Juckreiz am Augenlid
  • Keratitis
  • Netzhautablösung
  • Netzhautnarbe
  • Netzhautriss
  • okulärer Ikterus
  • Pupillenerkrankung
  • Ptosis des Augenlids
  • Reaktion an der Injektionsstelle
  • retinaler Arterienverschluss
  • retinale Exsudate
  • retinaler Venenverschluss und Glaskörperprolaps
  • Sehnervexkavation
  • Störung der Augenbewegung
  • vordere Uveitis
Weitere Nebenwirkungen nach Häufigkeit

Häufig
  • Kopfschmerzen
  • Rhinorrhö
Gelegentlich:
  • Änderung der Haarfarbe
  • Albträume
  • Aortenaneurysma
  • Ausschlag
  • Brustkorbschmerz
  • Depressionen
  • Druckempfindlichkeit
  • Dyspepsie
  • Ekzem
  • Erbrechen
  • erhöhte Aktivität der Gamma-Glutamyltransferase
  • Ermüdung
  • grippeähnliche Erkrankung
  • Hautabschürfungen
  • Herzklopfen
  • Hypertonie
  • Juckreiz
  • Kontaktdermatitis
  • nächtliche Schweißausbrüche
  • Nasopharyngitis
  • Rückenschmerzen
  • Schüttelfrost
  • Schwindel
  • Taubheit
  • Verschlechterung eines Morbus Menière