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Repeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment.

IMPORTANCEFor the management of retinal disease, the use of intravitreous injections of anti-vascular endothelial growth factor has increased. Recent reports have suggested that this therapy may cause sustained elevation of intraocular pressure (IOP) and may potentially increase the risk of glaucoma... Full description

Journal Title: JAMA ophthalmology May 2015, Vol.133(5), pp.589-597
Main Author: Bressler, Susan B
Other Authors: Almukhtar, Talat , Bhorade, Anjali , Bressler, Neil M , Glassman, Adam R , Huang, Suber S , Jampol, Lee M , Kim, Judy E , Melia, Michele , Bressler, Susan B
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 2168-6173 ; DOI: 2168-6173 ; DOI: 10.1001/jamaophthalmol.2015.186
Link: http://search.proquest.com/docview/1681259159/?pq-origsite=primo
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title: Repeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment.
format: Article
creator:
  • Bressler, Susan B
  • Almukhtar, Talat
  • Bhorade, Anjali
  • Bressler, Neil M
  • Glassman, Adam R
  • Huang, Suber S
  • Jampol, Lee M
  • Kim, Judy E
  • Melia, Michele
  • Bressler, Susan B
subjects:
  • Angiogenesis Inhibitors–Adverse Effects
  • Antibodies, Monoclonal, Humanized–Therapeutic Use
  • Antihypertensive Agents–Adverse Effects
  • Diabetic Retinopathy–Therapeutic Use
  • Female–Therapeutic Use
  • Humans–Drug Therapy
  • Intraocular Pressure–Drug Effects
  • Intravitreal Injections–Drug Therapy
  • Laser Coagulation–Drug Therapy
  • Macular Edema–Etiology
  • Male–Antagonists & Inhibitors
  • Middle Aged–Antagonists & Inhibitors
  • Ocular Hypertension–Antagonists & Inhibitors
  • Ranibizumab–Antagonists & Inhibitors
  • Retreatment–Antagonists & Inhibitors
  • Risk Factors–Antagonists & Inhibitors
  • Tonometry, Ocular–Antagonists & Inhibitors
  • Vascular Endothelial Growth Factor A–Antagonists & Inhibitors
  • Abridged
  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • Antihypertensive Agents
  • Vegfa Protein, Human
  • Vascular Endothelial Growth Factor A
  • Ranibizumab
ispartof: JAMA ophthalmology, May 2015, Vol.133(5), pp.589-597
description: IMPORTANCEFor the management of retinal disease, the use of intravitreous injections of anti-vascular endothelial growth factor has increased. Recent reports have suggested that this therapy may cause sustained elevation of intraocular pressure (IOP) and may potentially increase the risk of glaucoma for patients with retinal disease. OBJECTIVETo assess the risk of sustained IOP elevation or the need for IOP-lowering treatments for eyes with diabetic macular edema following repeated intravitreous injections of ranibizumab. DESIGN, SETTING, AND PARTICIPANTSAn exploratory analysis was conducted within a Diabetic Retinopathy Clinical Research Network randomized clinical trial. Study enrollment dates were from March 20, 2007, to December 17, 2008. Of 582 eyes (of 486 participants) with center-involved diabetic macular edema and no preexisting open-angle glaucoma, 260 were randomly assigned to receive a sham injection plus focal/grid laser treatment, and 322 were randomly assigned to receive ranibizumab plus deferred or prompt focal/grid laser treatment. MAIN OUTCOMES AND MEASURESThe cumulative probability of sustained IOP elevation, defined as IOP of at least 22 mm Hg and an increase of at least 6 mm Hg from baseline at 2 consecutive visits, or the initiation or augmentation of ocular hypotensive therapy, through 3 years of follow-up. RESULTSThe mean (SD) baseline IOP in both treatment groups was 16 (3) mm Hg (range, 5-24 mm Hg). The cumulative probability of sustained IOP elevation or of initiation or augmentation of ocular hypotensive therapy by 3 years, after repeated ranibizumab injections, was 9.5% for the participants who received ranibizumab plus prompt or deferred focal/grid laser treatment vs 3.4% for the participants who received a sham injection plus focal/grid laser treatment (difference, 6.1% [99% CI, -0.2% to 12.3%]; hazard ratio, 2.9 [99% CI, 1.0-7.9]; P = .01). The distribution of IOP and the change in IOP from baseline at each visit through 3 years were similar in each group. CONCLUSIONS AND RELEVANCEIn eyes with center-involved diabetic macular edema and no prior open-angle glaucoma, repeated intravitreous injections of ranibizumab may increase the risk of sustained IOP elevation or the need for ocular hypotensive treatment. Clinicians should be aware of this risk and should consider this information when following up with patients who have received intravitreous injections of anti-vascular endothelial growth factor for the treatment of diabet
language: eng
source:
identifier: E-ISSN: 2168-6173 ; DOI: 2168-6173 ; DOI: 10.1001/jamaophthalmol.2015.186
fulltext: fulltext
issn:
  • 21686173
  • 2168-6173
url: Link


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titleRepeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment.
creatorBressler, Susan B ; Almukhtar, Talat ; Bhorade, Anjali ; Bressler, Neil M ; Glassman, Adam R ; Huang, Suber S ; Jampol, Lee M ; Kim, Judy E ; Melia, Michele ; Bressler, Susan B
contributorMichelson, Joseph B (correspondence author) ; Kim, Judy E (record owner) ; Neely, Kimberly A ; Houghton, Odette M ; Wilker, Shawn C ; Gardner, Thomas W ; Sharma, Ashish G ; Vanderbeek, Brian L ; Rutledge, Bryan K ; Browning, David ; Do, Diana V ; Fan, Joseph T ; Maccumber, Mathew W ; Ghuman, A Thomas ; Hampton, G Robert ; Sharuk, George S ; Brown, Jamin S ; Walker, Joseph P ; Singerman, Lawrence J ; Raskauskas, Paul A ; Connor, Thomas B ; Brar, Vikram S ; Emerson, Geoffrey G ; Vemulakonda, Gurunadh Atmaram ; Singh, Harinderjit ; Woodcome, Harold A ; Jones, Jacob M ; Gross, Jeffrey G ; Elman, Michael J ; Lee, Michael S ; Dreyer, Richard F ; Bressler, Susan B ; Kuppermann, Baruch D ; Smith, Caldwell W ; Flaxel, Christina J ; Chan, Clement K ; Schlossman, Deborah K ; Tabandeh, Homayoun ; Hoskins, John C ; Kitchens, John W ; Plous, Oren Z ; Novack, Roger L ; Clark, W Lloyd ; Scott, Adrienne Williams ; Antoszyk, Andrew N ; Willis, Arthur W ; Lambert, H Michael ; Lim, Jennifer I ; Peters, Mark A ; Emerson, Michael Vaughn ; Lu, Stephanie Y ; Mein, Calvin E ; Cummings, Howard L ; Scott, Ingrid U ; Dhalla, Mandeep S ; Estafanous, Marc F G ; Francis, Peter J ; Smith, Stephen R ; Thompson, W Scott ; Brucker, Alexander J ; Ciardella, Antonio P ; Nuthi, Asha S D ; Quiroz-Mercado, Hugo ; Scott, Michael H ; Altaweel, Michael M ; Blair, Michael Paul ; Shami, Michel ; Bressler, Neil M ; Chace, Richard ; Isernhagen, Rick D ; Ray, Subhransu K ; Ting, T Daniel ; Cleary, Tina S ; Chen, Eric ; Fish, Gary E ; Schartman, Jerome P ; Grodin, Richard W ; Diaz-Rohena, Roberto ; Friedman, Scott M ; Solomon, Sharon D ; Hartnett, Mary Elizabeth R ; Novak, Michael A ; Ip, Michael S ; Gentile, Ronald C ; Blodi, Barbara A ; Leong, Craig J ; Ponce, Estuardo Alfonso ; Handelman, Irvin L ; Brown, Justin C ; Silva, Paolo S ; Liss, Robert A ; Shah, Sabera T ; Perkins, Stephen L ; Kaufman, Stephen R ; Huang, Suber S ; Mcmillan, Tod A ; Meredith, Travis A ; Lauer, Andreas K ; Berger, Brian B ; Jhaveri, Chirag D ; Weinberg, David V ; Wing, Glenn ; Chica, Moises A ; Wong, Robert W ; Grover, Sandeep ; Topping, Trexler M ; Wirostko, William J ; Wood, William J ; Greven, Craig Michael ; Miller, David G ; Han, Dennis P ; Kinyoun, James L ; Teasley, Laura Anne ; Aiello, Lloyd Paul ; Slusher, M Madison ; Arrigg, Paul G ; Spalding, Samuel C ; Baker, Carl W ; Wells, John A ; Tang, Johnny ; Khawly, Joseph A ; Nasir, Ma'an A ; Rauser, Michael E ; Maturi, Raj K ; Maturi, Raj K ; Glatzer, Ronald J ; Lin, Steven G ; Daniels, Stewart A ; Patel, Sunil S ; Hwang, Thomas S ; Pieramici, Dante J ; Salib, David M ; Marcus, Dennis M ; Lazarus, Howard S ; Stepien, Kimberly E ; Hrisomalos, Nicholas F ; Maturi, Raj K ; Anderson, Nicholas G ; Wang, Robert C ; Garg, Seema ; Stone, Thomas W ; Bhavsar, Abdhish R ; Castellarin, Alessandro A ; Lemley, Craig A ; Chau, Felix Y ; Rahman, Hassan T ; Sun, Jennifer K ; Pollack, John S ; Braverman, Jon M ; Coney, Joseph M ; Googe, Joseph M ; Gottlieb, Justin ; Chalam, Kakarla V ; Magee, Michael A ; Suthar, Mukesh Bhogilal ; Torrisi, Paul F ; Gupta, Shailesh K ; Bailey, Steven T ; Bailey, Steven T ; Bailey, Steven T
ispartofJAMA ophthalmology, May 2015, Vol.133(5), pp.589-597
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descriptionIMPORTANCEFor the management of retinal disease, the use of intravitreous injections of anti-vascular endothelial growth factor has increased. Recent reports have suggested that this therapy may cause sustained elevation of intraocular pressure (IOP) and may potentially increase the risk of glaucoma for patients with retinal disease. OBJECTIVETo assess the risk of sustained IOP elevation or the need for IOP-lowering treatments for eyes with diabetic macular edema following repeated intravitreous injections of ranibizumab. DESIGN, SETTING, AND PARTICIPANTSAn exploratory analysis was conducted within a Diabetic Retinopathy Clinical Research Network randomized clinical trial. Study enrollment dates were from March 20, 2007, to December 17, 2008. Of 582 eyes (of 486 participants) with center-involved diabetic macular edema and no preexisting open-angle glaucoma, 260 were randomly assigned to receive a sham injection plus focal/grid laser treatment, and 322 were randomly assigned to receive ranibizumab plus deferred or prompt focal/grid laser treatment. MAIN OUTCOMES AND MEASURESThe cumulative probability of sustained IOP elevation, defined as IOP of at least 22 mm Hg and an increase of at least 6 mm Hg from baseline at 2 consecutive visits, or the initiation or augmentation of ocular hypotensive therapy, through 3 years of follow-up. RESULTSThe mean (SD) baseline IOP in both treatment groups was 16 (3) mm Hg (range, 5-24 mm Hg). The cumulative probability of sustained IOP elevation or of initiation or augmentation of ocular hypotensive therapy by 3 years, after repeated ranibizumab injections, was 9.5% for the participants who received ranibizumab plus prompt or deferred focal/grid laser treatment vs 3.4% for the participants who received a sham injection plus focal/grid laser treatment (difference, 6.1% [99% CI, -0.2% to 12.3%]; hazard ratio, 2.9 [99% CI, 1.0-7.9]; P = .01). The distribution of IOP and the change in IOP from baseline at each visit through 3 years were similar in each group. CONCLUSIONS AND RELEVANCEIn eyes with center-involved diabetic macular edema and no prior open-angle glaucoma, repeated intravitreous injections of ranibizumab may increase the risk of sustained IOP elevation or the need for ocular hypotensive treatment. Clinicians should be aware of this risk and should consider this information when following up with patients who have received intravitreous injections of anti-vascular endothelial growth factor for the treatment of diabetic macular edema.
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1Almukhtar, Talat
2Bhorade, Anjali
3Bressler, Neil M
4Glassman, Adam R
5Huang, Suber S
6Jampol, Lee M
7Kim, Judy E
8Melia, Michele
titleRepeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment.
descriptionIMPORTANCEFor the management of retinal disease, the use of intravitreous injections of anti-vascular endothelial growth factor has increased. Recent reports have suggested that this therapy may cause sustained elevation of intraocular pressure (IOP) and may potentially increase the risk of glaucoma for patients with retinal disease. OBJECTIVETo assess the risk of sustained IOP elevation or the need for IOP-lowering treatments for eyes with diabetic macular edema following repeated intravitreous injections of ranibizumab. DESIGN, SETTING, AND PARTICIPANTSAn exploratory analysis was conducted within a Diabetic Retinopathy Clinical Research Network randomized clinical trial. Study enrollment dates were from March 20, 2007, to December 17, 2008. Of 582 eyes (of 486 participants) with center-involved diabetic macular edema and no preexisting open-angle glaucoma, 260 were randomly assigned to receive a sham injection plus focal/grid laser treatment, and 322 were randomly assigned to receive ranibizumab plus deferred or prompt focal/grid laser treatment. MAIN OUTCOMES AND MEASURESThe cumulative probability of sustained IOP elevation, defined as IOP of at least 22 mm Hg and an increase of at least 6 mm Hg from baseline at 2 consecutive visits, or the initiation or augmentation of ocular hypotensive therapy, through 3 years of follow-up. RESULTSThe mean (SD) baseline IOP in both treatment groups was 16 (3) mm Hg (range, 5-24 mm Hg). The cumulative probability of sustained IOP elevation or of initiation or augmentation of ocular hypotensive therapy by 3 years, after repeated ranibizumab injections, was 9.5% for the participants who received ranibizumab plus prompt or deferred focal/grid laser treatment vs 3.4% for the participants who received a sham injection plus focal/grid laser treatment (difference, 6.1% [99% CI, -0.2% to 12.3%]; hazard ratio, 2.9 [99% CI, 1.0-7.9]; P = .01). The distribution of IOP and the change in IOP from baseline at each visit through 3 years were similar in each group. CONCLUSIONS AND RELEVANCEIn eyes with center-involved diabetic macular edema and no prior open-angle glaucoma, repeated intravitreous injections of ranibizumab may increase the risk of sustained IOP elevation or the need for ocular hypotensive treatment. Clinicians should be aware of this risk and should consider this information when following up with patients who have received intravitreous injections of anti-vascular endothelial growth factor for the treatment of diabetic macular edema.
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0Angiogenesis Inhibitors–Adverse Effects
1Antibodies, Monoclonal, Humanized–Therapeutic Use
2Antihypertensive Agents–Adverse Effects
3Diabetic Retinopathy–Therapeutic Use
4Female–Therapeutic Use
5Humans–Drug Therapy
6Intraocular Pressure–Drug Effects
7Intravitreal Injections–Drug Therapy
8Laser Coagulation–Drug Therapy
9Macular Edema–Etiology
10Male–Antagonists & Inhibitors
11Middle Aged–Antagonists & Inhibitors
12Ocular Hypertension–Antagonists & Inhibitors
13Ranibizumab–Antagonists & Inhibitors
14Retreatment–Antagonists & Inhibitors
15Risk Factors–Antagonists & Inhibitors
16Tonometry, Ocular–Antagonists & Inhibitors
17Vascular Endothelial Growth Factor A–Antagonists & Inhibitors
18Abridged
19Angiogenesis Inhibitors
20Antibodies, Monoclonal, Humanized
21Antihypertensive Agents
22Vegfa Protein, Human
23Vascular Endothelial Growth Factor A
24Ranibizumab
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7Vanderbeek, Brian L
8Rutledge, Bryan K
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11Fan, Joseph T
12Maccumber, Mathew W
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14Hampton, G Robert
15Sharuk, George S
16Brown, Jamin S
17Walker, Joseph P
18Singerman, Lawrence J
19Raskauskas, Paul A
20Connor, Thomas B
21Brar, Vikram S
22Emerson, Geoffrey G
23Vemulakonda, Gurunadh Atmaram
24Singh, Harinderjit
25Woodcome, Harold A
26Jones, Jacob M
27Gross, Jeffrey G
28Elman, Michael J
29Lee, Michael S
30Dreyer, Richard F
31Bressler, Susan B
32Kuppermann, Baruch D
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34Flaxel, Christina J
35Chan, Clement K
36Schlossman, Deborah K
37Tabandeh, Homayoun
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53Scott, Ingrid U
54Dhalla, Mandeep S
55Estafanous, Marc F G
56Francis, Peter J
57Smith, Stephen R
58Thompson, W Scott
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60Ciardella, Antonio P
61Nuthi, Asha S D
62Quiroz-Mercado, Hugo
63Scott, Michael H
64Altaweel, Michael M
65Blair, Michael Paul
66Shami, Michel
67Bressler, Neil M
68Chace, Richard
69Isernhagen, Rick D
70Ray, Subhransu K
71Ting, T Daniel
72Cleary, Tina S
73Chen, Eric
74Fish, Gary E
75Schartman, Jerome P
76Grodin, Richard W
77Diaz-Rohena, Roberto
78Friedman, Scott M
79Solomon, Sharon D
80Hartnett, Mary Elizabeth R
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83Gentile, Ronald C
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titleRepeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment.
authorBressler, Susan B ; Almukhtar, Talat ; Bhorade, Anjali ; Bressler, Neil M ; Glassman, Adam R ; Huang, Suber S ; Jampol, Lee M ; Kim, Judy E ; Melia, Michele ; Bressler, Susan B
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2Antihypertensive Agents–Adverse Effects
3Diabetic Retinopathy–Therapeutic Use
4Female–Therapeutic Use
5Humans–Drug Therapy
6Intraocular Pressure–Drug Effects
7Intravitreal Injections–Drug Therapy
8Laser Coagulation–Drug Therapy
9Macular Edema–Etiology
10Male–Antagonists & Inhibitors
11Middle Aged–Antagonists & Inhibitors
12Ocular Hypertension–Antagonists & Inhibitors
13Ranibizumab–Antagonists & Inhibitors
14Retreatment–Antagonists & Inhibitors
15Risk Factors–Antagonists & Inhibitors
16Tonometry, Ocular–Antagonists & Inhibitors
17Vascular Endothelial Growth Factor A–Antagonists & Inhibitors
18Abridged
19Angiogenesis Inhibitors
20Antibodies, Monoclonal, Humanized
21Antihypertensive Agents
22Vegfa Protein, Human
23Vascular Endothelial Growth Factor A
24Ranibizumab
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8Melia, Michele
9Michelson, Joseph B
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12Wilker, Shawn C
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15Vanderbeek, Brian L
16Rutledge, Bryan K
17Browning, David
18Do, Diana V
19Fan, Joseph T
20Maccumber, Mathew W
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31Vemulakonda, Gurunadh Atmaram
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34Jones, Jacob M
35Gross, Jeffrey G
36Elman, Michael J
37Lee, Michael S
38Dreyer, Richard F
39Kuppermann, Baruch D
40Smith, Caldwell W
41Flaxel, Christina J
42Chan, Clement K
43Schlossman, Deborah K
44Tabandeh, Homayoun
45Hoskins, John C
46Kitchens, John W
47Plous, Oren Z
48Novack, Roger L
49Clark, W Lloyd
50Scott, Adrienne Williams
51Antoszyk, Andrew N
52Willis, Arthur W
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54Lim, Jennifer I
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58Mein, Calvin E
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60Scott, Ingrid U
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59Brucker, Alexander J
60Ciardella, Antonio P
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62Quiroz-Mercado, Hugo
63Scott, Michael H
64Altaweel, Michael M
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75Schartman, Jerome P
76Grodin, Richard W
77Diaz-Rohena, Roberto
78Friedman, Scott M
79Solomon, Sharon D
80Hartnett, Mary Elizabeth R
81Novak, Michael A
82Ip, Michael S
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84Blodi, Barbara A
85Leong, Craig J
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91Shah, Sabera T
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93Kaufman, Stephen R
94Huang, Suber S
95McMillan, Tod A
96Meredith, Travis A
97Lauer, Andreas K
98Berger, Brian B
99Jhaveri, Chirag D
100...
atitleRepeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment.
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genrearticle
ristypeJOUR
abstractIMPORTANCEFor the management of retinal disease, the use of intravitreous injections of anti-vascular endothelial growth factor has increased. Recent reports have suggested that this therapy may cause sustained elevation of intraocular pressure (IOP) and may potentially increase the risk of glaucoma for patients with retinal disease. OBJECTIVETo assess the risk of sustained IOP elevation or the need for IOP-lowering treatments for eyes with diabetic macular edema following repeated intravitreous injections of ranibizumab. DESIGN, SETTING, AND PARTICIPANTSAn exploratory analysis was conducted within a Diabetic Retinopathy Clinical Research Network randomized clinical trial. Study enrollment dates were from March 20, 2007, to December 17, 2008. Of 582 eyes (of 486 participants) with center-involved diabetic macular edema and no preexisting open-angle glaucoma, 260 were randomly assigned to receive a sham injection plus focal/grid laser treatment, and 322 were randomly assigned to receive ranibizumab plus deferred or prompt focal/grid laser treatment. MAIN OUTCOMES AND MEASURESThe cumulative probability of sustained IOP elevation, defined as IOP of at least 22 mm Hg and an increase of at least 6 mm Hg from baseline at 2 consecutive visits, or the initiation or augmentation of ocular hypotensive therapy, through 3 years of follow-up. RESULTSThe mean (SD) baseline IOP in both treatment groups was 16 (3) mm Hg (range, 5-24 mm Hg). The cumulative probability of sustained IOP elevation or of initiation or augmentation of ocular hypotensive therapy by 3 years, after repeated ranibizumab injections, was 9.5% for the participants who received ranibizumab plus prompt or deferred focal/grid laser treatment vs 3.4% for the participants who received a sham injection plus focal/grid laser treatment (difference, 6.1% [99% CI, -0.2% to 12.3%]; hazard ratio, 2.9 [99% CI, 1.0-7.9]; P = .01). The distribution of IOP and the change in IOP from baseline at each visit through 3 years were similar in each group. CONCLUSIONS AND RELEVANCEIn eyes with center-involved diabetic macular edema and no prior open-angle glaucoma, repeated intravitreous injections of ranibizumab may increase the risk of sustained IOP elevation or the need for ocular hypotensive treatment. Clinicians should be aware of this risk and should consider this information when following up with patients who have received intravitreous injections of anti-vascular endothelial growth factor for the treatment of diabetic macular edema.
doi10.1001/jamaophthalmol.2015.186
urlhttp://search.proquest.com/docview/1681259159/
issn21686165
date2015-05-01