Ocular Discomfort Assessment After Intravitreal Injections

Diabetic Retinopathy Clinical Trial

— EVAGO  

Official title:

Evaluation de la gêne Oculaire après Injections intravitréennes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806830
• Other study ID #: EVAGO
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: July 27, 2017
• Start date: April 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, ocular discomfort following intravitreal injection in naïve patients will be studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular discomfort.

Description:

In naive patients, the two first intravitreal injections will be studied. Within the first injection, no wetting agent will be delivered. Within 72hours after this first intravitreal injections, patients will be contacted by phone by a nurse to complete questionnaires on quality of life and on ocular pain and eye discomfort.

After the second injection, a treatment with wetting agent will be prescribed. With 72hours after the second injection, quality of life, ocular discomfort as well as acceptability and tolerance of the eye drops will also be assessed by a phone questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 1, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old

• Patient with social healthcare

• Patient understanding French language

• Patient requiring anti-VEGF treatment by intravitreal injection

Exclusion Criteria:

• Patient treated by Ozurdex® before

• Patient with known and treated ocular dryness

• Non naive patient for intravitreal injection

• Hypersensitivity to Carmellose

• Patient who received wetting agent within the 3 last months

• History of povidone-iodine allergy

• Pregnant or breastfeeding mother

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Degeneration
• Myopia
• Myopia, Degenerative
• Retinal Artery Occlusion
• Retinal Diseases

Intervention

Drug:
• Optive
Optive eye drops will be prescribed to each included patients after their second intravitreal injection; patients will received 1 drop in the affected eye 2 times a day during 3 days

Locations

Country	Name	City	State
France	Chi Creteil	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

References & Publications (8)

Ba J, Peng RS, Xu D, Li YH, Shi H, Wang Q, Yu J. Intravitreal anti-VEGF injections for treating wet age-related macular degeneration: a systematic review and meta-analysis. Drug Des Devel Ther. 2015 Sep 28;9:5397-405. doi: 10.2147/DDDT.S86269. eCollection 2015. Review. — View Citation

Massamba N, Elluard M, Agoune W, Guyader V, Ingram A, Pasquier B, Knoeri J. Assessment of ocular pain following ranibizumab intravitreal injection. Acta Ophthalmol. 2015 May;93(3):e231-2. doi: 10.1111/aos.12531. Epub 2014 Aug 13. — View Citation

Massin P, Bandello F, Garweg JG, Hansen LL, Harding SP, Larsen M, Mitchell P, Sharp D, Wolf-Schnurrbusch UE, Gekkieva M, Weichselberger A, Wolf S. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care. 2010 Nov;33(11):2399-405. doi: 10.2337/dc10-0493. — View Citation

Meyer CH, Krohne TU, Charbel Issa P, Liu Z, Holz FG. Routes for Drug Delivery to the Eye and Retina: Intravitreal Injections. Dev Ophthalmol. 2016;55:63-70. doi: 10.1159/000431143. Epub 2015 Oct 26. Review. — View Citation

Nghiem-Buffet S, Cohen SY. [Retinal vein occlusion: anti-VEGF treatments]. J Fr Ophtalmol. 2009 Nov;32(9):679-86. doi: 10.1016/j.jfo.2009.10.002. Epub 2009 Oct 29. Review. French. — View Citation

Pe'er J, Folberg R, Itin A, Gnessin H, Hemo I, Keshet E. Vascular endothelial growth factor upregulation in human central retinal vein occlusion. Ophthalmology. 1998 Mar;105(3):412-6. — View Citation

Salam A, DaCosta J, Sivaprasad S. Anti-vascular endothelial growth factor agents for diabetic maculopathy. Br J Ophthalmol. 2010 Jul;94(7):821-6. doi: 10.1136/bjo.2009.163576. Epub 2009 Jun 24. Review. — View Citation

Stewart MW. The clinical utility of aflibercept for diabetic macular edema. Diabetes Metab Syndr Obes. 2015 Sep 18;8:473-82. doi: 10.2147/DMSO.S72792. eCollection 2015. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients		within the 72h after the first and the second intravitreal injections