PMID- 32211907
OWN - NLM
STAT- MEDLINE
DCOM- 20210414
LR  - 20210414
IS  - 2325-8179 (Electronic)
IS  - 2325-8160 (Linking)
VI  - 51
IP  - 3
DP  - 2020 Mar 1
TI  - Prevention of Macular Edema in Patients With Diabetic Retinopathy Undergoing 
      Cataract Surgery: The PROMISE Trial.
PG  - 170-178
LID - 10.3928/23258160-20200228-06 [doi]
AB  - BACKGROUND AND OBJECTIVE: To determine the safety and efficacy of intravitreal 
      aflibercept injection (IAI) in patients with diabetic retinopathy (DR) in the 
      prevention of macular edema (ME) following cataract surgery. PATIENTS AND 
      METHODS: This phase 2, prospective, interventional, single-masked, randomized 
      trial at a single academic center included 30 patients who were 18 years of age 
      or older with nonproliferative DR and undergoing cataract surgery with 
      phacoemulsification. Patients received 2 mg intravitreal aflibercept (0.05 mL) or 
      sham injection during cataract surgery. Main outcome measures included treatment 
      adverse events (AEs), best-corrected visual acuity (BCVA), and incidence of ME 
      (defined as presence of cystoid abnormalities as detected by optical coherence 
      tomography at any follow-up visit), a 30% or greater increase from preoperative 
      baseline in central subfield macular thickness, or a BCVA decrease of more than 5 
      ETDRS letters from Day 7 due to retinal thickening. RESULTS: There were similar 
      incidences of AEs between the two groups and no clinically serious ocular AEs in 
      either group. The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = 
      .022), but there was no significant difference in ME events at Day 30 (27% vs. 
      60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = 
      .161). Compared to the study group, the control group had a significantly greater 
      increase in central subfield thickness (CST) at Day 30 (50.05 mum vs. 7.95 mum; P = 
      .040) and Day 60 (56.45 mum vs. 3.02 mum; P = .010). However, the difference in CST 
      between groups was no longer significant at Day 90 (50.31 mum vs. 18.48 mum; P = 
      .12). There were no significant differences in BCVA gains between the IAI and 
      sham group at the end of the follow-up period (Day 90, ETDRS letters: 9.88 vs. 
      8.52; P = .66). CONCLUSIONS: Use of IAI in patients with DR for prevention of ME 
      following cataract surgery showed no significant AEs. Although there were 
      significant differences in ME incidence and retinal thickness at periods of time, 
      there was no clinically meaningful benefit in terms of VA. Further larger trials 
      are needed to validate these findings. [Ophthalmic Surg Lasers Imaging Retina. 
      2020;51:170-178.].
CI  - Copyright 2020, SLACK Incorporated.
FAU - Song, Weilin
AU  - Song W
FAU - Conti, Thais F
AU  - Conti TF
FAU - Gans, Richard
AU  - Gans R
FAU - Conti, Felipe F
AU  - Conti FF
FAU - Silva, Fabiana Q
AU  - Silva FQ
FAU - Saroj, Namrata
AU  - Saroj N
FAU - Singh, Rishi P
AU  - Singh RP
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ophthalmic Surg Lasers Imaging Retina
JT  - Ophthalmic surgery, lasers & imaging retina
JID - 101599215
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 15C2VL427D (aflibercept)
RN  - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/administration & dosage
MH  - Cataract/*complications
MH  - *Cataract Extraction
MH  - Diabetic Retinopathy/*complications/diagnosis
MH  - Female
MH  - Fluorescein Angiography
MH  - Follow-Up Studies
MH  - Fundus Oculi
MH  - Humans
MH  - Intravitreal Injections
MH  - Macula Lutea/pathology
MH  - Macular Edema/diagnosis/etiology/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Preoperative Care/*methods
MH  - Prospective Studies
MH  - Receptors, Vascular Endothelial Growth Factor/*administration & 
      dosage/antagonists & inhibitors
MH  - Recombinant Fusion Proteins/*administration & dosage
MH  - Single-Blind Method
MH  - Tomography, Optical Coherence
MH  - Treatment Outcome
MH  - Visual Acuity
EDAT- 2020/03/27 06:00
MHDA- 2021/04/15 06:00
CRDT- 2020/03/27 06:00
PHST- 2019/07/31 00:00 [received]
PHST- 2019/12/09 00:00 [accepted]
PHST- 2020/03/27 06:00 [entrez]
PHST- 2020/03/27 06:00 [pubmed]
PHST- 2021/04/15 06:00 [medline]
AID - 10.3928/23258160-20200228-06 [doi]
PST - ppublish
SO  - Ophthalmic Surg Lasers Imaging Retina. 2020 Mar 1;51(3):170-178. doi: 
      10.3928/23258160-20200228-06.