PMID- 34185587
OWN - NLM
STAT- MEDLINE
DCOM- 20211124
LR  - 20211124
IS  - 2325-8179 (Electronic)
IS  - 2325-8160 (Linking)
VI  - 52
IP  - 6
DP  - 2021 Jun
TI  - Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A 
      Multicenter, Phase 2a, Randomized, Clinical Trial.
PG  - 327-335
LID - 10.3928/23258160-20210528-05 [doi]
AB  - BACKGROUND AND OBJECTIVE: To evaluate the safety and efficacy of 1.0 mg 
      risuteganib in subjects with nonexudative age-related macular degeneration (AMD). 
      PATIENTS AND METHODS: This was a phase 2a, prospective, double-masked, 
      sham-controlled study. Eyes with nonexudative (dry) AMD and Early Treatment 
      Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 
      20/40 and 20/200 were included. Subjects were randomized to intravitreal 1.0 mg 
      risuteganib or sham injection. At Week 16, subjects in the risuteganib group 
      received a second 1.0-mg dose and the sham group crossed over to receive a dose 
      of 1.0 mg risuteganib and were evaluated at Week 28. The primary endpoint was 
      proportion of subjects with 8 letters ETDRS or more BCVA gain from baseline to 
      Week 28 in the risuteganib group versus baseline to Week 12 for the sham group. 
      BCVA was tested and subjects were observed for adverse events (AEs) every 4 weeks 
      until completion of the study at 32 weeks. RESULTS: Forty-five subjects 
      (risuteganib, n = 29; sham, n = 16) were enrolled in the study, of whom 39 
      (risuteganib, n = 25; sham, n = 14) completed the study and were included in the 
      per protocol efficacy analysis. At baseline, mean age was 78.8 and 75.9 years and 
      mean BCVA was 67.1 and 64.4 letters in the sham and risuteganib groups, 
      respectively. The primary endpoint was met by 48% of the risuteganib group at 
      Week 28 and 7% of the sham group at Week 12 (P = .013). Of the risuteganib 
      subjects, 20% gained 15 letters or more at Week 28, whereas no patients in the 
      sham group at Week 12 achieved this visual acuity gain. The only ocular 
      treatment-related treatment-emergent AE was vitreous floaters, which 
      spontaneously recovered without sequelae. No drug-related serious AE was 
      reported. CONCLUSIONS: Risuteganib demonstrated significant BCVA improvement in 
      patients with non-exudative AMD. No drug-related AEs were seen during a 32-week 
      observation period. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:327-335.].
FAU - Boyer, David S
AU  - Boyer DS
FAU - Gonzalez, Victor H
AU  - Gonzalez VH
FAU - Kunimoto, Derek Y
AU  - Kunimoto DY
FAU - Maturi, Raj K
AU  - Maturi RK
FAU - Roe, Richard H
AU  - Roe RH
FAU - Singer, Michael A
AU  - Singer MA
FAU - Xavier, Samantha
AU  - Xavier S
FAU - Kornfield, Julie A
AU  - Kornfield JA
FAU - Kuppermann, Baruch D
AU  - Kuppermann BD
FAU - Quiroz-Mercado, Hugo
AU  - Quiroz-Mercado H
FAU - Aubel, Janine
AU  - Aubel J
FAU - Karageozian, Hampar L
AU  - Karageozian HL
FAU - Park, John Y
AU  - Park JY
FAU - Karageozian, Vicken H
AU  - Karageozian VH
FAU - Karageozian, Lisa
AU  - Karageozian L
FAU - Sarayba, Melvin A
AU  - Sarayba MA
FAU - Kaiser, Peter K
AU  - Kaiser PK
LA  - eng
SI  - ClinicalTrials.gov/NCT03626636
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210601
PL  - United States
TA  - Ophthalmic Surg Lasers Imaging Retina
JT  - Ophthalmic surgery, lasers & imaging retina
JID - 101599215
RN  - 0 (Angiogenesis Inhibitors)
SB  - IM
MH  - *Angiogenesis Inhibitors/therapeutic use
MH  - *Diabetic Retinopathy/drug therapy
MH  - Double-Blind Method
MH  - Humans
MH  - Intravitreal Injections
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Visual Acuity
EDAT- 2021/06/30 06:00
MHDA- 2021/11/25 06:00
CRDT- 2021/06/29 17:12
PHST- 2021/06/29 17:12 [entrez]
PHST- 2021/06/30 06:00 [pubmed]
PHST- 2021/11/25 06:00 [medline]
AID - 10.3928/23258160-20210528-05 [doi]
PST - ppublish
SO  - Ophthalmic Surg Lasers Imaging Retina. 2021 Jun;52(6):327-335. doi: 
      10.3928/23258160-20210528-05. Epub 2021 Jun 1.