eMedicine Specialties > Ophthalmology > Retina

Neovascular Membranes, Subretinal: Treatment & Medication

Author: Steve Charles, MD, Director of Charles Retina Institute; Clinical Professor, Department of Ophthalmology, University of Tennessee College of Medicine; Adjunct Professor of Ophthalmology, Columbia College of Physicians & Surgeons; Clinical Professor Ophthalmology, Chinese University of Hong Kong
Contributor Information and Disclosures

Updated: Nov 13, 2009

Treatment

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.54
  • Lucentis (ranibizumab) is an anti-VEGF monoclonal antibody fragment. The US Food and Drug Administration (FDA)-approved dose of Lucentis is 0.5 mg (0.05 mL) administered by intravitreal injection.55,56
    • In pivotal Phase III clinical trials, Lucentis was administered once a month for up to 2 years.57,58,59 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 according to the package label.
    • Monthly injections were used in the pivotal clinical trials, but many retinal specialists have switched to a treat and observe paradigm primarily using OCT evidence of subretinal fluid and/or retinal edema as an indication for retreatment. More recently, many retinal specialists use FA leakage, vision, visual complaints, and presence of hemorrhage or exudate, in addition to OCT, to determine the need for reinjection. Because of the concern that recurrences occasionally result in poor outcomes, many retinal specialists now use a treat and extend strategy; "booster shots" are given after leakage is eliminated, and the follow-up interval is extended to 6 weeks. If the lesion is dry at 6 weeks, another booster shot is given, and the follow-up interval is extended to 8 weeks.
    • 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 30-31 gauge needle that 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.60 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 one Lucentis clinical trial, 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; none of which have been shown to be related to the drug.
    • Approximately 50% of retinal specialists use off-label Avastin, instead of the FDA-approved Lucentis, using a similar treatment schedule and indications for retreatment. The NEI sponsored CATT trial is a head-to-head randomized multicenter comparison of Lucentis to Avastin using with both monthly and PRN treatment arms.
    • Monotherapy with Avastin is very effective and is widely used off-label for CNV not due to wet AMD.
  • Photodynamic therapy using verteporfin was the first therapy for CNV approved by the 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 2005.61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,43,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135
  • 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).136,137
  • 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 4.138
  • In the VIP Study, patients with occult but no classic CNV had better outcomes than patients who received the placebo.139,140,141
  • 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 abandoned as monotherapy.142 It lasts for about 3 months.
  • Various biodegradable and nonbiodegradable intravitreal steroid implants are currently in clinical trials. Triesence (Alcon) is a preservative free, triamcinolone acetonide that was approved by the FDA in 2008.
  • Steroid glaucoma (~30%) and cataracts (~90%) are very common with the use of 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.143,144,145,146,147,148,149,150,151,152
    • 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.
  • Macugen (pegaptanib sodium injection) is an anti-VEGF aptamer.153 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. Plasmin and matrix metalloproteinases cleave the 165 and larger isoforms, rendering incorrect the argument that Macugen is more selective.
    • 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.154
    • Macugen is much less effective than Lucentis and has been largely abandoned after Avastin and Lucentis became available. Although some physicians recommend induction with Lucentis or Avastin and maintenance with Macugen, no studies support this strategy.
  • 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.155,156 An intraocular radiation device is currently being evaluated in a clinical trial (NeoVista) but is unlikely to be effective as monotherapy and requires a surgical procedure.
  • Retaane (anecortave acetate), a cortisone-type angiostatic steroid with no glucocorticoid activity, has been shown to be ineffective.
  • 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. This drug has not been approved by the FDA, and there is no ongoing study likely to result in its approval.
  • VEGF-trap (a fusion protein), small interfering RNA molecule, receptor tyrosine kinase inhibitor (RTKi), and rapamycin (sirolimus) are currently being studied and show some promise.
  • 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 with laser because of an immediate loss of 5 lines of vision and the availability of Lucentis and Avastin (off-label use).

Surgical Care

  • In 1991, Thomas and Kaplan reported a series of patients operated on for subfoveal CNVMs secondary to POHS.157 Subsequent series included CNV associated with AMD, angioid streaks, myopic degeneration, and idiopathic CNV.158,159,160 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) 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.161 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.162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181
  • 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 oroutpouching.182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,41,42,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,174,175,244,245,246,36,247,248,249,250,251,252,253,254,255,256
  • 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.257,258,259,260,261,262,263,264,265,266,267,268 Significant aniseikonia, high astigmatism, diplopia, enophthalmos, and ptosis are associated with limited macular translocation.269,270,271,272 Major cycloversion and diplopia are associated with retinal rotation methods.273,274,275,276,277,278,279,280,281,282,283 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

Anti-VEGF therapy

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


Pegaptanib (Macugen)

Selective VEGF antagonist that promotes vision stability and reduces visual acuity loss and progression to legal blindness. VEGF causes angiogenesis and increases vascular permeability and inflammation, all of which contribute to neovascularization in age-related wet macular degeneration.

Adult

0.3 mg injected intravitreal into affected eye q6wk

Pediatric

Not established

Ocular or periocular infections

Pregnancy

B - Fetal risk not confirmed in studies in humans but has been shown in some studies in animals

Precautions

Intravitreous injections have been associated with endophthalmitis; use proper aseptic technique; may increase IOP; most frequent adverse effects reported in 10-40% of patients over 24 mo include anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities

More on Neovascular Membranes, Subretinal

Overview: Neovascular Membranes, Subretinal
Differential Diagnoses & Workup: Neovascular Membranes, Subretinal
Treatment & Medication: Neovascular Membranes, Subretinal
Follow-up: Neovascular Membranes, Subretinal
References
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Further Reading

[ CLOSE WINDOW ]

Keywords

subretinal neovascular membrane, choroidal neovascular membrane, CNVM, choroidal neovascularization, CNV, SRNVM, exudative macular degeneration, wet macular degeneration

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Contributor Information and Disclosures

Author

Steve Charles, MD, Director of Charles Retina Institute; Clinical Professor, Department of Ophthalmology, University of Tennessee College of Medicine; Adjunct Professor of Ophthalmology, Columbia College of Physicians & Surgeons; Clinical Professor Ophthalmology, Chinese University of Hong Kong
Steve Charles, MD is a member of the following medical societies: American Academy of Ophthalmology, American Society of Retina Specialists, Club Jules Gonin, Macula Society, and Retina Society
Disclosure: Alcon Laboratories Consulting fee Consulting; OptiMedica Ownership interest Consulting

Medical Editor

V Al Pakalnis, MD, PhD, Professor of Ophthalmology, University of South Carolina School of Medicine; Chief of Ophthalmology, Dorn Veterans Affairs Medical Center
V Al Pakalnis, MD, PhD is a member of the following medical societies: American Academy of Ophthalmology, American College of Surgeons, and South Carolina Medical Association
Disclosure: Nothing to disclose.

Pharmacy Editor

Simon K Law, MD, PharmD, Assistant Professor of Ophthalmology, Jules Stein Eye Institute; Chief of Section of Ophthalmology Surgical Services, Department of Veterans Affairs Healthcare Center, West Los Angeles
Simon K Law, MD, PharmD is a member of the following medical societies: American Academy of Ophthalmology, American Glaucoma Society, and Association for Research in Vision and Ophthalmology
Disclosure: Nothing to disclose.

Managing Editor

Steve Charles, MD, Director of Charles Retina Institute; Clinical Professor, Department of Ophthalmology, University of Tennessee College of Medicine; Adjunct Professor of Ophthalmology, Columbia College of Physicians & Surgeons; Clinical Professor Ophthalmology, Chinese University of Hong Kong
Steve Charles, MD is a member of the following medical societies: American Academy of Ophthalmology, American Society of Retina Specialists, Club Jules Gonin, Macula Society, and Retina Society
Disclosure: Alcon Laboratories Consulting fee Consulting; OptiMedica Ownership interest Consulting

CME Editor

Lance L Brown, OD, MD, Ophthalmologist, Affiliated With Freeman Hospital and St John's Hospital, Regional Eye Center, Joplin, Missouri
Disclosure: Nothing to disclose.

Chief Editor

Hampton Roy Sr, MD, Associate Clinical Professor, Department of Ophthalmology, University of Arkansas for Medical Sciences
Hampton Roy Sr, MD is a member of the following medical societies: American Academy of Ophthalmology, American College of Surgeons, and Pan-American Association of Ophthalmology
Disclosure: Nothing to disclose.

 
 
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