NCT02806830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

June 14, 2016

Last Update Submit

July 27, 2017

Conditions

Macular DegenerationDiabetic RetinopathyRetinal Artery OcclusionMyopia, Degenerative

Keywords

Intravitreal injectionAMDDiabetic RetinopathyRetinal Artery OcclusionMyopia, Degenerativeeye drops

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Optive after the second anti-VEGF injection

EXPERIMENTAL

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)

Drug: Optive

Interventions

OptiveDRUG

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

Optive after the second anti-VEGF injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 18 years old
  • Patient with social healthcare
  • Patient understanding French language
  • Patient requiring anti-VEGF treatment by intravitreal injection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi Creteil

Créteil, 94000, France

Location

Related 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.

    PMID: 26451092BACKGROUND

  • 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.

    PMID: 9499769BACKGROUND

  • 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.

    PMID: 19879018BACKGROUND

  • 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.

    PMID: 19556214BACKGROUND

  • 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.

    PMID: 20980427BACKGROUND

  • 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.

    PMID: 26425104BACKGROUND

  • 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.

    PMID: 25123226BACKGROUND

  • 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.

    PMID: 26501462BACKGROUND

MeSH Terms

Conditions

Macular DegenerationDiabetic RetinopathyRetinal Artery OcclusionMyopia, Degenerative

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesArterial Occlusive DiseasesMyopiaRefractive Errors

Study Officials

  • Oudy SEMOUN, MD

    CHI Créteil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in ophtalmology

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 21, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2017

Study Completion

July 1, 2017

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)