Macular DegenerationEVAGONCT02806830
Ocular Discomfort Assessment After Intravitreal Injections
A study testing Optive in people with Macular Degeneration and Diabetic Retinopathy, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Degeneration, Diabetic Retinopathy, Retinal Artery Occlusion
- What is being tested?
- Optive
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Patient with social healthcare
- Patient understanding French language
- Patient requiring anti-VEGF treatment by intravitreal injection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation de la gêne Oculaire après Injections intravitréennes
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.
- Conditions
- Macular Degeneration, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative
- Being tested
- Optive
- Keywords
- Intravitreal injection, AMD, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative, eye drops
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Optive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients
Measured: within the 72h after the first and the second intravitreal injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oudy SEMOUN, Centre Hospitalier Intercommunal Creteil
- Investigators
- Oudy SEMOUN, MD, Principal investigator, CHI Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806830
- Sponsor's protocol ID
- EVAGO
- Acronym
- EVAGO
- Status last verified
- Jul 2017
- First submitted
- 14 Jun 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 26451092Pe'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 9499769Nghiem-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 19879018Salam 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 19556214Massin 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 20980427Stewart 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 26425104Massamba 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 25123226Meyer 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de la gêne Oculaire après Injections intravitréennes
- ClinicalTrials.gov ID
- NCT02806830
- Acronym / sponsor ID
- EVAGO / EVAGO
- Conditions
- Macular Degeneration, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative
- Keywords
- Intravitreal injection, AMD, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative, eye drops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optive after the second anti-VEGF injection | Experimental | Drug: OptiveNaive 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Patient with social healthcare
- Patient understanding French language
- Patient requiring anti-VEGF treatment by intravitreal injection
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptiveOptive 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 | Drug | Optive after the second anti-VEGF injection |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Background: PubMed 26451092Ba 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.
- Background: PubMed 9499769Pe'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.
- Background: PubMed 19879018Nghiem-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.
- Background: PubMed 19556214Salam 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.
- Background: PubMed 20980427Massin 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.
- Background: PubMed 26425104Stewart 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.
- Background: PubMed 25123226Massamba 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.
- Background: PubMed 26501462Meyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oudy SEMOUN, MD principal investigator
CHI Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optive in people with Macular Degeneration and Diabetic Retinopathy, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02806830, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.