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CompletedNCT02806830EVAGOUpdated Jul 28, 2017

Ocular Discomfort Assessment After Intravitreal Injections

An interventional study of Optive in Macular Degeneration, Diabetic Retinopathy and Retinal Artery Occlusion, sponsored by Centre Hospitalier Intercommunal Creteil. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-28.

Sponsored by Centre Hospitalier Intercommunal Creteil · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

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

Keywords

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

Macular Degeneration

1,473 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 45 is below the median of 51 across 984 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Optive after the second anti-VEGF injection

    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

  • DrugOptive

    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

06

What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • Chi Creteil
    Creteil, 94000, France
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References and documents

Publications

  • 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. PubMed 26451092 ↗
  • 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. PubMed 9499769 ↗
  • 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. PubMed 19879018 ↗
  • 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. PubMed 19556214 ↗
  • 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. PubMed 20980427 ↗
  • 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. PubMed 26425104 ↗
  • 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. PubMed 25123226 ↗
  • 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. PubMed 26501462 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02806830
Lead sponsor
Centre Hospitalier Intercommunal Creteil
Responsible party
Oudy SEMOUN (Doctor in ophtalmology, Centre Hospitalier Intercommunal Creteil) — Principal investigator
First posted
Jun 21, 2016
Start date
Apr 2016
Primary completion
Jan 2017
Completion
Jul 1, 2017
Last update
Jul 28, 2017

Study contacts

Oudy SEMOUN, MD
principal investigator · CHI Créteil

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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