AUTHOR AND EDITOR INFORMATION

Section 1 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

INTRODUCTION

Section 2 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Background

Choroidal neovascular membranes (CNVMs) are associated with many diseases. The most common causes are age-related macular degeneration (AMD), presumed ocular histoplasmosis syndrome (POHS), myopic macular degeneration, trauma, and angioid streaks; however, many cases are idiopathic.

The natural history of patients with AMD should not be overlooked when pilot studies of new therapies are reported. In a randomized trial (of 481 patients) of interferon alpha-2, 62% of the placebo group stabilized at 1 year, losing less than 3 lines of vision. Randomized clinical trials are necessary in assessing treatment efficacy in cases of CNVMs secondary to AMD as well as other causes. Submacular surgery, photodynamic therapy, translocation, and transpupillary thermotherapy (TTT) have been advocated as a means of stabilizing vision, where stable is defined as vision that is unchanged as opposed to a modest reduction in the rate of vision loss. A therapy that purports to stabilize vision requires large numbers of patients in a randomized trial with long-term follow-up to prove stabilization.

Subfoveal CNVMs do not result in a loss of ambulatory vision if untreated. The natural history of subfoveal CNVMs never results in total blindness, while this outcome is all too frequent with macular translocation and occasionally with submacular surgery.

Pathophysiology

CNVMs may be thought of as the initial phase of a choroidal scar. Because these structures angiographically demonstrate a network of vessels, they are often referred to as "nets." The early phase of these lesions is termed exudative, while the later phase is termed cicatricial. Increased permeability of new vessels to fluorescein and indocyanine green (ICG) creates the familiar angiographic appearance referred to as leakage.

Vascular endothelial growth factor (VEGF) is present during the neovascularization phase. Because the scars are often circular in nature, they are called disciform scars when they enter the cicatricial phase. CNVMs, like all scarring disorders, seem to be a repair process with tissue loss or damage initiating the repair activity. The cause of tissue destruction in AMD is probably apoptosis, programmed cellular death. POHS, trauma, laser therapy, and angioid streaks all have in common a defect in the retinal pigment epithelium (RPE) and/or choriocapillaris. Localized hypoxia related to increasing hydrophobic properties of the Bruch membrane may play a significant role.

Frequency

United States

The overall prevalence of neovascular AMD in people older than 40 years is estimated to be 1.47%.

Mortality/Morbidity

CNVMs and most related diseases are not characterized by increased mortality rates. Smoking increases the progression rate of AMD by 350-500%, and, of course, smoking dramatically increases cancer and cardiovascular death rates. Morbidity is limited to the loss of central vision; the peripheral vision is always retained in cases of CNVMs unless complications of surgical therapy occur.

Race

The incidence rate of AMD is less in blacks than in whites (see Age).

• Blue eyes are twice as likely as dark-colored eyes to develop AMD. AMD is the most frequent cause of CNVMs.
• Other causes of CNVMs are not associated with differences in racial incidence, except for angioid streaks associated with sickle cell disease and ethnic differences in the incidence of myopia.

Sex

Ocular trauma is more common in men than in women and is a known cause of CNVMs. AMD is more common in women than in men. No known significant sexual predilection exists for other causes of CNVMs.

Age

The prevalence of AMD increases rapidly with age.

• AMD is more common after age 60 years, with the frequency increasing for patients in their 70s and an even greater frequency for patients in their 80s. The frequency of AMD is 11.90% in white men older than 80 years and 16.39% in white women older than 80 years.
• Histoplasmosis typically occurs in the 30s or 40s.
• Angioid streaks occur in individuals aged 30-60 years.
• Myopic macular degeneration typically occurs after age 25 years.

CLINICAL

Section 3 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

History

• Patient complaints
• • Decreased central vision
  • Central or paracentral, relative or absolute scotomas
  • Distortion (metamorphopsia)
  • Central light flashes or flickering
  • Impaired color vision
  • Prolonged recovery from light stress

Physical

Perform an examination using a slit lamp biomicroscopy and a fundus contact lens or 60-, 78-, or 90-diopter (D) lens. Fluorescein angiography (FA) is required in virtually all cases. ICG angiography is useful in approximately 5-10% of cases. Optical coherence tomography (OCT) has become an essential part in the assessment of these patients.

• Clinical findings
• • Grey or ill-defined CNVMs can be subfoveal, juxtafoveal, extrafoveal, peripapillary, or even in the periphery. Experienced observers often visualize these lesions without angiography, although angiography is necessary in virtually all instances.
  • Subretinal hemorrhage is common and frequently outlines the CNVM. In some cases, very large choroidal hemorrhages occur that can be mistaken for malignant melanomas of the choroid.
  • Exudate, serous fluid, or both are often present with choroidal neovascularization (CNV). Angiographically well-defined membranes are referred to as classic. In many cases, the neovascular membrane is ill-defined and is termed occult. Large amounts of subretinal blood, fluid, or exudate may prevent clinical or angiographic visualization of the underlying CNVM.

Causes

AMD, POHS, myopia, trauma, angioid streaks, certain hereditary macular degenerations, and other causes of macular RPE damage have been associated with CNVM formation. Many cases are idiopathic.

DIFFERENTIALS

Section 4 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Other Problems to be Considered

AMD, geographic atrophy

WORKUP

Section 5 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Lab Studies

• No laboratory tests exist for most diseases associated with CNVMs.
• Hereditary macular degeneration can usually be identified from clinical presentation, family history, angiography, electroretinogram (ERG), electro-oculogram (EOG), and psychophysical testing (eg, color vision, perimetry, dark adaptation).
• The diagnosis of histoplasmosis is based on fundus findings not serologic or skin testing.
• Angioid streaks are usually due to pseudoxanthoma elasticum (PXE), but they have also been reported in patients with sickle cell disease and Paget disease.

Imaging Studies

• FA and ICG angiography are used in confirming the diagnosis, guiding laser and photodynamic therapy (PDT), and determining the efficacy of treatment. Digital angiography offers the advantages of immediate viewing, local area network (LAN) and/or wide area network (WAN) access, archiving, and incorporation into the computerized medical record, but it offers no better resolution than film-based imaging. Confocal laser scanning-based imaging dramatically improves the signal to background ratio by 15 dB, provides better illumination of the fluorophore, and improves image quality compared with that of a fundus camera–based digital imaging system. ICG angiography is needed in some cases.
• Retinal angiomatous proliferation (RAP) is common. RAP is best visualized with simultaneous confocal ICG angiography and FA; however, careful contact lens examination and FA alone is usually sufficient.

Histologic Findings

Biopsy is not performed in CNVM cases. If submacular surgery is performed (ie, non-AMD cases), histology is not needed, as many of these lesions have been studied; histology is of no value to the patient.

TREATMENT

Section 6 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Medical Care

• In the Age-Related Eye Disease Study (AREDS), zinc combined with other antioxidants has been shown to reduce the progression rate of AMD by 25% in patients with intermediate drusen.
• Alpha I interferon has been shown to be ineffective in several randomized trials.
• Macular photocoagulation of extrafoveal lesions has a 50% success rate, which is defined as preventing subfoveal extension of the CNV.
• • About 13% of patients with AMD and CNVM are eligible for this laser treatment.
  • Although the Macular Photocoagulation Study (MPS) included patients with subfoveal CNV, these patients are no longer being treated because of an immediate loss of 5 lines of vision.
• Photodynamic therapy using verteporfin was the first therapy for CNV approved by the US Food and Drug Administration (FDA), other than laser photocoagulation, but it is now rarely used because of the availability of ranibizumab (Lucentis) since June 2006 and the widespread off-label use of bevacizumab (Avastin) since July 2005.
• • In the Photodynamic Therapy (TAP) Study Group, patients with predominantly classic CNV were less likely (41% at 24 mo) to have moderate vision loss (3 lines) at 12 and 24 months than patients who received the placebo (69% at 24 mo).
  • The TAP Extension Study showed that the number of retreatments was 3.6 during Year 1, 2.3 during Year 2, 1.2 during Year 3, and 0.5 during Year 4.
  • In the VIP Study, patients with occult but no classic CNV had better outcomes than patients who received the placebo.
  • Patients with minimally classic CNV and who were treated with TAP were not statistically different than controls.
• Intravitreal triamcinolone acetonide reduces leakage in some CNV cases but has been largely abandoned as monotherapy. It lasts for about 3 months.
• • Various biodegradable and nonbiodegradable intravitreal steroid implants are currently in clinical trials.
  • Steroid glaucoma and cataracts are very common with long-term intravitreal steroids.
  • Intravitreal triamcinolone acetonide has been shown in small, prospective trials to be effective when given in conjunction with PDT. The rationale of steroids combined with PDT is reducing the up-regulation of VEGF known to be caused by PDT.
• TTT has been shown to be ineffective.
• • The results of the TTT4CNV Clinical Trial showed that, at 2 years, 47% of eyes avoided moderate or severe vision loss compared to 43% of control eyes, which was not statistically significant.
  • Follow-up at 18 and 24 months showed an advantage of approximately 4 letters in eyes treated with TTT, although this trend was not significant.
  • Additionally, 11% of patients who were treated with TTT, compared to 3% of patients who received placebo, showed improvement (increase of greater than or equal to 2 lines) from baseline when evaluated at 1 year. This secondary outcome was statistically significant.
• Retaane (anecortave acetate), a cortisone-type angiostatic steroid with no glucocorticoid activity, has been shown to be devoid of adverse effects in a Phase 2/3 Trial.
• • The drug is administered with a posterior juxtascleral cannula at 6-month intervals. Patients injected beyond 6 months had worse outcomes, thereby emphasizing that injections cannot be delayed past 6 months.
  • This trial demonstrated that reflux of the drug during injection reduced efficacy. Reflux must be prevented by using pressure on the conjunctiva and the Tenon capsule overlying the injection cannula and by slowly injecting and withdrawing the cannula.
  • Retaane was shown to be slightly less effective than PDT when the data included the 40% of patients who experienced reflux during the injection as well as those patients injected after 6 months. Retaane failed to meet the primary endpoint and received an approvable letter but was not approved by the FDA.
• Macugen (pegaptanib sodium injection) is an anti-VEGF aptamer. In humans, at least 5 subtypes or isoforms of VEGF exist. Two VEGF isoforms, isoforms 165 and 121, are present in the eye in meaningful levels; isoform 165 is required for abnormal blood vessel growth in the retina. Aptamers are chemically synthesized short strands of RNA (oligonucleotides) that adopt highly specific 3-dimensional conformations.
• • Macugen is a pegylated molecule, meaning that a molecule of polyethylene glycol (PEG) is attached to a strand of nucleic acid. Pegylation increases the half-life of the product, which, in turn, increases the time that Macugen is available in the eye to target VEGF.
  • Macugen is administered by intravitreal injection every 6 weeks.
  • Sterile technique using povidone iodine and a sterile speculum is essential to reduce the significant incidence of endophthalmitis, which was reported in the first half of the Phase 2/3 Trial.
• Lucentis (rhuFab V2, AMD Fab, ranibizumab) is an anti-VEGF monoclonal antibody fragment. The FDA-approved dose of Lucentis is 0.5 mg (0.05 mL) administered by intravitreal injection.
• • In pivotal Phase III clinical trials, Lucentis was administered once a month for up to 2 years. The benefits of treatment with Lucentis were also maintained in most patients for up to 2 years with continuous use. Treatment should be continued and monitored. Individual results may vary. In the pivotal clinical trials, some patients reported an improvement in vision starting at day 7 after treatment with Lucentis. However, just because a patient does not report an immediate improvement, it does not mean that Lucentis is not working. Some patients experience improvements later or merely do not lose significant vision with Lucentis.
  • Although less effective, treatment may be reduced to 1 injection every 3 months after the first 4 injections if monthly injections are not feasible. Compared to continual monthly dosing, dosing every 3 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average, over the following 9 months. Patients should be evaluated regularly.
  • Dosing is at the discretion of the physician.
  • Lucentis sets a new standard in the treatment of neovascular AMD because it is the first therapy proven to improve vision instead of simply slowing the decline of central vision loss. In clinical trials, up to 40% of patients gained 15 or more letters of vision and nearly all patients (up to 96%) maintained vision.
  • Lucentis is administered through a fine 30-gauge needle that, unlike needles of other therapies, most patients tolerate well.
  • Of patients treated with Lucentis, 94% remained on therapy for 1 year versus 89% of patients in the control groups. Lucentis has been studied in more than 1000 patients with neovascular AMD in 2 double-masked, controlled 2-year studies.
  • Lucentis is indicated for the treatment of patients with neovascular (wet) AMD.
  • Lucentis is contraindicated in patients with ocular or periocular infections.
  • Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis and retinal detachment. Proper aseptic injection technique should always be used when administering Lucentis. Patients should be monitored during the week following the injection to permit early treatment, should an infection occur.
  • Increases in intraocular pressure (IOP) have been noted within 60 minutes of intravitreal injection. IOP and perfusion of the optic nerve head should be monitored and managed appropriately.
  • Although a low rate ( <4%) of arterial thromboembolic events (ATEs) was observed in the Lucentis clinical trials, a theoretical risk of ATEs exists following intravitreal use of VEGF inhibitors.
  • Serious adverse events related to the injection procedure occurring in less than 0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract. Other serious ocular events occurring in less than 2% of patients included intraocular inflammation and increased IOP.
  • In clinical trials, the most common ocular adverse effects included conjunctival hemorrhage, eye pain, and vitreous floaters. The most common nonocular adverse effects included hypertension, nasopharyngitis, headache, and upper respiratory tract infection.
• Plasmapheresis (MFD) did not meet the primary endpoint in a multicenter clinical trial and, therefore, was not approved by the FDA. The rationale is elusive, and no scientific evidence exists of its efficacy.
• Beta irradiation and proton beam irradiation have been shown to be ineffective in several randomized clinical trials.
• Squalamine is a systemically administered antiangiogenic. It is the first clinical drug candidate in a class of naturally occurring, pharmacologically active, small molecules known as aminosterols. Squalamine is a potent molecule with a unique multifaceted mechanism of action that blocks the action of a number of angiogenic growth factors, including VEGF, cytoskeleton, and integrin expression.
• • The initial trial of squalamine in the treatment of AMD demonstrated early evidence of squalamine activity, as demonstrated by shrinkage of the size of the CNV lesions associated with AMD in some patients and by stabilization of these lesions in other patients. In patients treated with squalamine, certain individuals had improvement of 3 lines or greater of vision, and nearly all patients had stabilization of vision. The greatest degree of improvement was 8 lines, that is, visual acuity improved from 20/125 to 20/20.
  • Squalamine is administered intravenously, thereby eliminating the risks of eye infection and eye injury.
  • This drug has not been approved by the FDA, and there is no ongoing study likely to result in its approval.

Surgical Care

• In 1991, Thomas and Kaplan reported a series of patients operated on for subfoveal CNVMs secondary to POHS. Subsequent series included CNV associated with AMD, angioid streaks, myopic degeneration, and idiopathic CNV. Idiopathic cases have the best results, followed by POHS cases. Most studies showed poor results for patients with AMD (approximately 20% had better vision, 60% had the same vision, and 20% had worse vision). Some surgeons state that submacular surgery for CNVM in patients with AMD may result in stabilization. Again, it must be emphasized that this procedure may also result in complete loss of vision, which is not true of the natural course of the disease. Results of the Submacular Surgery Trial (SST) have demonstrated that submacular surgery is ineffective in AMD and POHS.
• RPE transplantation has been used for patients with AMD by some investigators; 100% of patients undergo rejection of cadaver RPE, requiring immune suppression in those patients without a life-threatening disease. Transplanted RPE cells do not become adherent to the Bruch membrane so the RPE cells would have to be transplanted as a sheet in combination with the Bruch membrane and probably choriocapillaris. Use of nasal RPE and iris pigment epithelium is currently being studied. Many biologic, practical, and ethical issues are associated with sourcing RPE cells for transplantation. Transplantation is not a viable therapy at this time.
• Macular translocation has been advocated for subfoveal CNV. One procedure uses vitrectomy, creation of a total retinal detachment, and a 360-degree retinotomy followed by retinal rotation. An alternate method, termed limited macular translocation, is based on retinal detachment creation and scleral imbrication or outpouching. Many eyes have been lost as a result of these procedures. Bleeding, retinal detachment, proliferative vitreoretinopathy (PVR), macular holes, new neovascular membranes, and good anatomical results without visual improvement are frequent complications of translocation. Significant aniseikonia, high astigmatism, diplopia, enophthalmos, and ptosis are associated with limited macular translocation. Major cycloversion and diplopia are associated with retinal rotation methods. Neither form of translocation has sufficient safety and efficacy to be indicated for general use.

Consultations

In most cases, general ophthalmologists should consult retina specialists.

Diet

Eating spinach, kale, mustard greens, turnip greens, collard greens, nuts, and oily fish reduce the progression rate of patients with signs of early AMD, as reported in the Beaver Dam Eye Study.

Activity

High blood pressure could theoretically result in bleeding from active neovascularization. Smoking increases the risk of AMD progression by 350-500%.

MEDICATION

Section 7 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Drug Category: Anti-VEGF therapy

Reduces risk of visual loss similar to that seen with photodynamic therapy.

FOLLOW-UP

Section 8 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Further Inpatient Care

• All medical and surgical treatments for CNV can be performed in an outpatient setting.

Further Outpatient Care

• Postsubmacular surgery patients require a first postoperative day visit, followed by a 2- to 3-week visit. Thereafter, any time that the patient notes a change in the Amsler grid, a visit should be scheduled.

Transfer

• Retinal specialists should manage patients with CNV.

Complications

• Recurrent CNVs occur in 25-50% of submacular surgery cases.
• Cataracts occur frequently after vitreoretinal surgery.
• Subretinal, suprachoroidal, and vitreous hemorrhage can occur after surgery.
• Retinal detachment can occur after surgery.
• Endophthalmitis can occur after any ocular surgery or intravitreal injection.
• Steroid glaucoma occurs 20-30% of the time after intravitreal injection of Kenalog.

Prognosis

• There is a 25-50% chance of recurrent CNV after submacular surgery. Submacular hemorrhage is not uncommon after submacular surgery. Postoperative vision typically is limited by recurrences, damage to the RPE, and overlying retina.

Patient Education

• Advise patients to use the Amsler grid to monitor their central fields daily.
• For excellent patient education resources, visit eMedicine's Eye and Vision Center. Also, see eMedicine's patient education article Macular Degeneration.

MISCELLANEOUS

Section 9 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Medical/Legal Pitfalls

• Failure to inform patients about recurrences and complications might result in litigation based on informed consent.
• Submacular surgery should not be used for AMD, and TTT should not be used for CNV due to AMD.

REFERENCES

Section 10 of 10

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

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