Age-related Macular DegenerationNCT02707575
Cytokeratin 8 Level in Age-related Macular Degeneration
An observational study of Age-related Macular Degeneration, run by Gangnam Severance Hospital at 2 sites in South Korea.
Trial summary
The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes with exudative age-related macular degeneration (AMD) before therapy with intravitreal Ranibizumab, and identify associations with visual and anatomical outcome after treatment. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- How many people
- 58 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 26 Apr 2016to 23 Apr 2018
- Phase
- Observational
- 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Included patient is required to be least 50 years of age with newly diagnosed exudative age-related macular degeneration, with a recent onset of disease.
Who may be able to join
- Treatment-naive neovascular AMD patients requiring intravitreal injection of Ranibizumab
- A recent onset of disease confirmed by history and clinical findings.
- Patient is required to be least 50 years of age
Who cannot join
- Myopia with a refractive error >-3.0 diopters or evidence of pathologic myopia (pre-operative refractive data were used to assess pseudophakic eyes)
- Any history of vitrectomy, anti-VEGF therapy, or photodynamic therapy (PDT)
- History of cataract surgery within 3 months prior to presentation
- Evidence of end-stage AMD such as subfoveal fibrosis or atrophy
- Evidence of other retinal diseases including central serous chorioretinopathy and other neovascularmaculopathies; glaucoma; poor imaging data caused by media opacity; or unstable fixation
- Patients with uncontrolled systemic diseases, use of immunosuppressive drugs, or malignant tumors of any location
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Inje University Ilsan Paik Hospital
Goyang
Gangnam Severance Hospital
Seoul
About this study
Official title: Cytokeratin 8 Level in Aqueous Humor, as a Prognostic Factor for Visual and Anatomical Outcomes After Ranibizumab (Lucentis) in Neovascular Age-related Macular Degeneration
The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes with exudative age-related macular degeneration (AMD) before therapy with intravitreal Ranibizumab, and identify associations with visual and anatomical outcome after treatment.
Read the detailed description
In this non-randomized, and open-label study, the investigators will prospectively evaluate 58 patients with treatment naive exudative age-related macular degeneration (AMD) who receive intravitreal ranibizumab injection. A mean volume of 0.1 ml of aqueous humor samples will be taken each time an intravitreal injection is indicated and performed. Cytokeratin 8 level in aqueous humor will be evaluated, and associations of baseline cytokeratin 8 level and visual (the best corrected visual acuity change) and anatomical (optical coherence tomography parameters) after Ranibizumab injection will be investigated.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Ranibizumab
- Keywords
- Keratin, Ranibizumab
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Three monthly consecutive injections of 0.5-mg ranibizumab will be performed. Aqueous humor samples will be taken each time an intravitreal injection in indicated and performed.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Intravitreal Ranibizumab Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity
The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity
Measured: From baseline to one month after three monthly consecutive ranibizumab injection
Secondary outcomes (1)
The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT)
The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT)
Measured: From baseline to one month after three monthly consecutive ranibizumab injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start26 Apr 2016
- Primary completion12 Mar 2018
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Konkuk University, Inje University, Novartis, Severance Hospital
- Responsible party
- Principal investigator, Suk Ho Byeon, Gangnam Severance Hospital
- Investigators
- Suk Ho Byeon, MD. Ph.D., Principal investigator, Professor. Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707575
- Sponsor's protocol ID
- 3-2015-0304
- Status last verified
- Dec 2020
- First submitted
- 3 Mar 2016
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokeratin 8 Level in Aqueous Humor, as a Prognostic Factor for Visual and Anatomical Outcomes After Ranibizumab (Lucentis) in Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02707575
- Acronym / sponsor ID
- 3-2015-0304
- Conditions
- Age-related Macular Degeneration
- Keywords
- Keratin, Ranibizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Collaborators
- Konkuk University, Inje University, Novartis, Severance Hospital
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 14 Mar 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.
The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes with exudative age-related macular degeneration (AMD) before therapy with intravitreal Ranibizumab, and identify associations with visual and anatomical outcome after treatment.
Detailed description
In this non-randomized, and open-label study, the investigators will prospectively evaluate 58 patients with treatment naive exudative age-related macular degeneration (AMD) who receive intravitreal ranibizumab injection. A mean volume of 0.1 ml of aqueous humor samples will be taken each time an intravitreal injection is indicated and performed. Cytokeratin 8 level in aqueous humor will be evaluated, and associations of baseline cytokeratin 8 level and visual (the best corrected visual acuity change) and anatomical (optical coherence tomography parameters) after Ranibizumab injection will be investigated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | – | Drug: RanibizumabIntravitreal Ranibizumab |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included patient is required to be least 50 years of age with newly diagnosed exudative age-related macular degeneration, with a recent onset of disease.
Key inclusion criteria (3 listed)
- Treatment-naive neovascular AMD patients requiring intravitreal injection of Ranibizumab
- A recent onset of disease confirmed by history and clinical findings.
- Patient is required to be least 50 years of age
Key exclusion criteria (6 listed)
- Myopia with a refractive error >-3.0 diopters or evidence of pathologic myopia (pre-operative refractive data were used to assess pseudophakic eyes)
- Any history of vitrectomy, anti-VEGF therapy, or photodynamic therapy (PDT)
- History of cataract surgery within 3 months prior to presentation
- Evidence of end-stage AMD such as subfoveal fibrosis or atrophy
- Evidence of other retinal diseases including central serous chorioretinopathy and other neovascularmaculopathies; glaucoma; poor imaging data caused by media opacity; or unstable fixation
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 |
|---|---|---|
| RanibizumabAlso: LucentisThree monthly consecutive injections of 0.5-mg ranibizumab will be performed. Aqueous humor samples will be taken each time an intravitreal injection in indicated and performed. | Drug | Ranibizumab |
Primary outcome
The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity
Time frame: From baseline to one month after three monthly consecutive ranibizumab injection
The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity
1 secondary outcome
The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT)
Time frame: From baseline to one month after three monthly consecutive ranibizumab injection
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 9 Dec 2020.
- 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.
Suk Ho Byeon, MD. Ph.D. principal investigator
Professor. Yonsei University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Macular Degeneration, run by Gangnam Severance Hospital at 2 sites in South Korea.
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 3 inclusion and 6 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity (time frame: From baseline to one month after three monthly consecutive ranibizumab injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2020.