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Ocular Discomfort Assessment After Intravitreal Injections (EVAGO)

Primary Purpose

Macular Degeneration, Diabetic Retinopathy, Retinal Artery Occlusion

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Optive

About this trial

This is an interventional supportive care trial for Macular Degeneration focused on measuring Intravitreal injection, AMD, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative, eye drops

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chi Creteil

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optive after the second anti-VEGF injection

Arm Description

Naive patients requiring intravitreal injection. Patients will be enrolled in this study within the 2 first intravitreal injections to assess quality of life and ocular discomfort without wetting agent (ie after the first injection) and with wetting agent (ie after the second injection)

Outcomes

Primary Outcome Measures

Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients

Secondary Outcome Measures

Full Information

NCT ID

NCT02806830

First Posted

June 14, 2016

Last Updated

July 27, 2017

Sponsor

Centre Hospitalier Intercommunal Creteil

1. Study Identification

Unique Protocol Identification Number

NCT02806830

Brief Title

Ocular Discomfort Assessment After Intravitreal Injections

Acronym

EVAGO

Official Title

Evaluation de la gêne Oculaire après Injections intravitréennes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Intercommunal Creteil

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Intravitreal injection, AMD, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative, eye drops

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Optive after the second anti-VEGF injection

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Optive

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients

Time Frame

within the 72h after the first and the second intravitreal injections

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oudy SEMOUN, MD

Organizational Affiliation

CHI Créteil

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chi Creteil

City

Creteil

ZIP/Postal Code

94000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26451092

Citation

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.

Results Reference

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PubMed Identifier

9499769

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. doi: 10.1016/S0161-6420(98)93020-2.

Results Reference

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PubMed Identifier

19879018

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. French.

Results Reference

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PubMed Identifier

19556214

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.

Results Reference

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PubMed Identifier

20980427

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.

Results Reference

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PubMed Identifier

26425104

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.

Results Reference

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PubMed Identifier

25123226

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. No abstract available.

Results Reference

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PubMed Identifier

26501462

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.

Results Reference

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Ocular Discomfort Assessment After Intravitreal Injections

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