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Predictive factors of better outcomes by monotherapy of an antivascular endothelial growth factor drug, ranibizumab, for diabetic macular edema in clinical practice.

Abstract Intravitreal ranibizumab (IVR) has been approved for treating diabetic macular edema (DME), and is used in daily clinical practice. However, the treatment efficacies of IVR monotherapy in real-world clinical settings are not well known.The medical records of 56 eyes from 38 patients who received their first IVR for DME between April 2014 and March 2015, and were retreated with IVR monotherapy as needed with no rescue treatment, such as laser photocoagulation, were retrospectively reviewed. The clinical course, best-corrected visual acuity (BCVA), and fundus findings at baseline, before the initial IVR injection, and at 12 months, were evaluated.Twenty-five eyes from 25 patients (16 men; mean age 68.7 ± 9.8 years) who received IVR in the first eye, or unilaterally, without any other treatments during follow-up were included. After 12 months, mean central retinal thickness (CRT), which includes edema, was reduced (P = .003), although mean BCVA remained unchanged. There was a negative correlation between individual changes in BCVA (r = -0.57; P = .003) and CRT (r = -0.60; P = .002) at 12 months compared with baseline values. BCVA changes were greater in individuals with a history of pan-retinal photocoagulation at baseline (P = .026). After adjusting for age and sex, CRT improvement >100 μm at 12 months was associated with a greater CRT at baseline (OR 0.87 per 10 μm [95% CI 0.72-0.97]; P = .018) according to logistic regression analyses; however, better BCVA and CRT at 12 months were associated with a better BCVA (r = 0.77; P < .001) and lower CRT (r = 0.41; P = .039) at baseline, respectively, according to linear regression analyses.IVR monotherapy suppressed DME, and the effects varied according to baseline conditions. Eyes that had poorer BCVA or greater CRT, or a history of pan-retinal photocoagulation at baseline, demonstrated greater improvement with IVR monotherapy. In contrast, to achieve better outcome values, DME eyes should be treated before the BCVA and CRT deteriorate. These findings advance our understanding of the optimal use of IVR for DME in daily clinical practice, although further study is warranted.
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Journal Title medicine
Publication Year Start




PMID- 28422835
OWN - NLM
STAT- MEDLINE
DA  - 20170419
DCOM- 20170501
LR  - 20170501
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Linking)
VI  - 96
IP  - 16
DP  - 2017 Apr
TI  - Predictive factors of better outcomes by monotherapy of an antivascular
      endothelial growth factor drug, ranibizumab, for diabetic macular edema in
      clinical practice.
PG  - e6459
LID - 10.1097/MD.0000000000006459 [doi]
AB  - Intravitreal ranibizumab (IVR) has been approved for treating diabetic macular
      edema (DME), and is used in daily clinical practice. However, the treatment
      efficacies of IVR monotherapy in real-world clinical settings are not well
      known.The medical records of 56 eyes from 38 patients who received their first
      IVR for DME between April 2014 and March 2015, and were retreated with IVR
      monotherapy as needed with no rescue treatment, such as laser photocoagulation,
      were retrospectively reviewed. The clinical course, best-corrected visual acuity 
      (BCVA), and fundus findings at baseline, before the initial IVR injection, and at
      12 months, were evaluated.Twenty-five eyes from 25 patients (16 men; mean age
      68.7 +/- 9.8 years) who received IVR in the first eye, or unilaterally, without
      any other treatments during follow-up were included. After 12 months, mean
      central retinal thickness (CRT), which includes edema, was reduced (P = .003),
      although mean BCVA remained unchanged. There was a negative correlation between
      individual changes in BCVA (r = -0.57; P = .003) and CRT (r = -0.60; P = .002) at
      12 months compared with baseline values. BCVA changes were greater in individuals
      with a history of pan-retinal photocoagulation at baseline (P = .026). After
      adjusting for age and sex, CRT improvement &gt;100 mum at 12 months was associated
      with a greater CRT at baseline (OR 0.87 per 10 mum [95% CI 0.72-0.97]; P = .018) 
      according to logistic regression analyses; however, better BCVA and CRT at 12
      months were associated with a better BCVA (r = 0.77; P &lt; .001) and lower CRT (r =
      0.41; P = .039) at baseline, respectively, according to linear regression
      analyses.IVR monotherapy suppressed DME, and the effects varied according to
      baseline conditions. Eyes that had poorer BCVA or greater CRT, or a history of
      pan-retinal photocoagulation at baseline, demonstrated greater improvement with
      IVR monotherapy. In contrast, to achieve better outcome values, DME eyes should
      be treated before the BCVA and CRT deteriorate. These findings advance our
      understanding of the optimal use of IVR for DME in daily clinical practice,
      although further study is warranted.
FAU - Sato, Shinri
AU  - Sato S
AD  - aDepartment of Ophthalmology bLaboratory of Retinal Cell Biology, Keio
      University, School of Medicine, Tokyo, Japan.
FAU - Shinoda, Hajime
AU  - Shinoda H
FAU - Nagai, Norihiro
AU  - Nagai N
FAU - Suzuki, Misa
AU  - Suzuki M
FAU - Uchida, Atsuro
AU  - Uchida A
FAU - Kurihara, Toshihide
AU  - Kurihara T
FAU - Kamoshita, Mamoru
AU  - Kamoshita M
FAU - Tomita, Yohei
AU  - Tomita Y
FAU - Iyama, Chigusa
AU  - Iyama C
FAU - Minami, Sakiko
AU  - Minami S
FAU - Yuki, Kenya
AU  - Yuki K
FAU - Tsubota, Kazuo
AU  - Tsubota K
FAU - Ozawa, Yoko
AU  - Ozawa Y
LA  - eng
PT  - Journal Article
PT  - Observational Study
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Angiogenesis Inhibitors)
RN  - ZL1R02VT79 (Ranibizumab)
SB  - AIM
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/*administration &amp; dosage
MH  - Angiography
MH  - Diabetic Retinopathy/diagnosis/*drug therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Intravitreal Injections
MH  - Linear Models
MH  - Macular Edema/diagnosis/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Ranibizumab/*administration &amp; dosage
MH  - Retina/diagnostic imaging/drug effects
MH  - Retrospective Studies
MH  - Tomography, Optical Coherence
MH  - Treatment Outcome
PMC - PMC5406051
EDAT- 2017/04/20 06:00
MHDA- 2017/05/02 06:00
CRDT- 2017/04/20 06:00
AID - 10.1097/MD.0000000000006459 [doi]
AID - 00005792-201704210-00016 [pii]
PST - ppublish
SO  - Medicine (Baltimore). 2017 Apr;96(16):e6459. doi: 10.1097/MD.0000000000006459.

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