NCT03946267 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Baba T, Hagiwara A, Sato E, Arai M, Oshitari T, Yamamoto S
Comparison of vitrectomy with brilliant blue G or indocyanine green on retinal microstructure and function of eyes with macular hole. Ophthalmology. 2012 Dec;119(12):2609-15. doi: 10.1016/j.ophtha.2012.06.048. Epub 2012 Aug 24.
Burk SE, Da Mata AP, Snyder ME, Rosa RH Jr, Foster RE
Indocyanine green-assisted peeling of the retinal internal limiting membrane. Ophthalmology. 2000 Nov;107(11):2010-4.
Haritoglou C, Tadayoni R, May CA, Gass CA, Freyer W, Priglinger SG, Kampik A
Short-term in vivo evaluation of novel vital dyes for intraocular surgery. Retina. 2006 Jul-Aug;26(6):673-8.
Iriyama A, Uchida S, Yanagi Y, Tamaki Y, Inoue Y, Matsuura K, Kadonosono K, Araie M
Effects of indocyanine green on retinal ganglion cells. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):943-7.
Michalewska Z, Michalewski J, Adelman RA, Nawrocki J
Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.
Park JH, Lee SM, Park SW, Lee JE, Byon IS
Comparative analysis of large macular hole surgery using an internal limiting membrane insertion versus inverted flap technique. Br J Ophthalmol. 2019 Feb;103(2):245-250. doi: 10.1136/bjophthalmol-2017-311770. Epub 2018 Apr 2.
Schmid-Kubista KE, Lamar PD, Schenk A, Stolba U, Binder S
Comparison of macular function and visual fields after membrane blue or infracyanine green staining in vitreoretinal surgery. Graefes Arch Clin Exp Ophthalmol. 2010 Mar;248(3):381-8. doi: 10.1007/s00417-009-1213-4. Epub 2009 Oct 13.

Infracyanine Green vs Brilliant Blue G in Inverted Flap Surgery for Medium to Large Macular Holes: A Swept Source OCT Analysis.

Details for clinical trial NCT03946267

Clinical trial NCT03946267 - References