Exudative Age-related Macular DegenerationNCT03744806
Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular AMD
An observational study of Exudative Age-related Macular Degeneration, run by Medical University of Lublin.
Trial summary
The aim of this study is to evaluate the effect of repeated intravitreal bevacizumab injections on blood-aqueous barrier permeability in eyes with neovascular age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- What is being tested?
- Bevacizumab Injection
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- active AMD-associated choroidal neovascularization (CNV) confirmed with fluorescein angiography (FA) and optical coherence tomography (OCT)
Who cannot join
- history of uveitis, vitreous hemorrhage, neovascular glaucoma, corneal opacities, recent ocular surgery (within 3 months), or prior anti- vascular endothelial growth factor (VEGF) injections
About this study
Official title: Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular Age-related Macular Degeneration
The aim of this study is to evaluate the effect of repeated intravitreal bevacizumab injections on blood-aqueous barrier permeability in eyes with neovascular age-related macular degeneration (AMD).
- Being tested
- Bevacizumab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| treated with intravitreal bevacizumab. | Not described Receives: Drug: Bevacizumab Injection | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber (AC) inflammation evaluated with laser flare photometry.
All patients were examined before and 1 day and 1 month after each intravitreal bevacizumab injection. Subjects were followed for a period of 4 months in both the study and control groups. The final flare photometry value was automatically calculated by averaging 5 individual measurements. A total of 7 measurements were obtained, but the highest and lowest measurement values were excluded by the flare meter. All statistical analyses were performed using STATISTICA 12 statistical software.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study startJan 2015
- Primary completionSep 2015
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744806
- Sponsor's protocol ID
- KE-0254/208/2013
- Status last verified
- Nov 2018
- First submitted
- 22 Mar 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03744806
- Acronym / sponsor ID
- KE-0254/208/2013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 16 Nov 2018 (actual)
- 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 aim of this study is to evaluate the effect of repeated intravitreal bevacizumab injections on blood-aqueous barrier permeability in eyes with neovascular age-related macular degeneration (AMD).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated with intravitreal bevacizumab. | – | Drug: Bevacizumab Injection |
| control group | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- active AMD-associated choroidal neovascularization (CNV) confirmed with fluorescein angiography (FA) and optical coherence tomography (OCT)
Key exclusion criteria (1 listed)
- history of uveitis, vitreous hemorrhage, neovascular glaucoma, corneal opacities, recent ocular surgery (within 3 months), or prior anti- vascular endothelial growth factor (VEGF) injections
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 |
|---|---|---|
| Bevacizumab Injection | Drug | treated with intravitreal bevacizumab. |
Primary outcome
Anterior chamber (AC) inflammation evaluated with laser flare photometry.
Time frame: 4 months
All patients were examined before and 1 day and 1 month after each intravitreal bevacizumab injection. Subjects were followed for a period of 4 months in both the study and control groups. The final flare photometry value was automatically calculated by averaging 5 individual measurements. A total of 7 measurements were obtained, but the highest and lowest measurement values were excluded by the flare meter. All statistical analyses were performed using STATISTICA 12 statistical software.
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 16 Nov 2018.
Related trials for Exudative Age-related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Exudative Age-related Macular Degeneration, run by Medical University of Lublin.
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 1 inclusion and 1 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Anterior chamber (AC) inflammation evaluated with laser flare photometry. (time frame: 4 months). 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 16 Nov 2018.