Neovascular Age Related Macular Degeneration (AMD)Phase 4NCT01983579
TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection
A Phase 4 study testing Intraocular anti-VEGF injection and SENSIMED Triggerfish in people with Neovascular Age Related Macular Degeneration (AMD) and Open Angle Glaucoma, run by Sensimed AG at 1 site in Spain.
Trial summary
This is a prospective, open label study assessing the 24-hour IOP patterns using TF in patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related macular degeneration). The study will be proposed to patients with AMD and patients with AMD and concomitant open angle glaucoma (OAG). Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Neovascular Age Related Macular Degeneration (AMD), Open Angle Glaucoma
- What is being tested?
- Intraocular anti-VEGF injection and SENSIMED Triggerfish
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Feb 2014
- Phase
- Phase 4
- 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
Who may be able to join
- Diagnosis of neovascular AMD or neovascular AMD with concomitant OAG
- For neovascular AMD patients, IOP <21 mmHg, normal RNFL (retinal nerve fiber layer) thickness and optic disc, in need of treatment with monthly anti-VEGF injections and with best-corrected Snellen visual acuity of 0.5 or better on the non-study eye
- For OAG patients, open angle, with typical glaucomatous optic disc including diffuse or localized neuroretinal rim loss, excavation, and retinal nerve fiber layer defects, or repeated abnormal visual field defined as a pattern standard deviation outside of the 95% normal confidence limits or a Glaucoma Hemifield Test result outside normal limits
- For OAG patients any IOP-lowering treatment should be unchanged since at least 4 weeks at study entry and remain stable throughout the study
- Aged ≥ 50 years
- Not more than 6 diopters spherical refraction equivalent in the study eye
- Having given written informed consent, prior to any investigational procedures
Who cannot join
- Pigmentary glaucoma, exfoliative glaucoma, narrow or closed iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye
- History of ocular incision or laser surgery on the study eye (except cataract extraction)
- Corneal or conjunctival abnormality in the study eye precluding contact lens adaptation
- Severe dry eye syndrome
- Subjects with irregular sleep schedule or with sleep apnea syndrome
- Subjects allergic to silicone
Show all 9Show fewer
- Subjects not able to understand the character and individual consequences of the investigation
- Participation in other clinical research within the last 4 weeks
- Any other contra-indication listed in the TF user manual
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open Label, Prospective Study Assessing the IOP (Intraocular Pressure) Patterns Using SENSIMED Triggerfish® in Association With Anti-VEGF Injection
This is a prospective, open label study assessing the 24-hour IOP patterns using TF in patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related macular degeneration). The study will be proposed to patients with AMD and patients with AMD and concomitant open angle glaucoma (OAG).
The study will be conducted in two stages. In both stages, patients will remain ambulatory and will be encouraged to follow a schedule as close to their usual lifestyle as possible, with the exception of particular activities such as caffeine intake, playing wind instruments, yoga and strenuous exercise. A patient diary will be distributed for the capture of patient activities during the TF pattern recording. Upon completion of each session, the CLS (contact lens sensor) will be removed and a final ophthalmic examination will be conducted.
Read more
In the first stage of the study, 20 patients with neovascular AMD with an IOP in the normal range and no concomitant glaucoma will be recruited. After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. One eye will be selected for the study. If both eyes are eligible, the study eye will be selected in random manner.
All 20 AMD patients will receive two 24-hour recording sessions (S) with the TF CLS, at monthly interval. In the first session (S1) anti-VEGF injection will be carried out according to the study center standard protocol. For the second 24-hour TF recording session (S2), patients will be randomly distributed into three groups. Group A, consisting of 5 patients, will receive anti-VEGF injection with a different anti-VEGF substance as compared to S1. Group B, also consisting of 5 patients, will receive anti-VEGF without sclerotomy occlusion after injection as compared to S1. Finally, group C, including 10 patients, will receive anti-VEGF in a different dose (injection volume) as compared to S1. The randomization ratio between groups A, B and C is 1:1:2.
The overall study duration for an eligible patient in the first stage of this study is limited to 5 weeks.
If in the first stage of this study an injection protocol is identified that provokes significantly lesser elevation on the TF pattern, the alternative injection protocol will be evaluated against the current standard protocol. For the second stage, 30 patients of whom 15 with neovascular AMD and 15 with neovascular AMD and concomitant OAG will be recruited. After giving informed consent and confirmation of eligibility, all patients will receive two 24-hour TF CLS recording sessions (S3 and S4) at monthly interval, during which anti-VEGF injection according to the standard and alternative protocol will be carried out in random sequence.
The overall study duration for a patient in the second stage of the study is limited to 5 weeks.
The study has been planned to recruit 20 eligible patients in the first stage within 12 weeks from the date of initiation. The second stage will recruit 30 patients within 16 weeks. Hence the overall study duration from the first patient accrued into the study until last patient out equates to about 33 weeks. Allowing for a database lock within 4 weeks of study completion, a preliminary statistical report on the primary efficacy endpoint is foreseen within 2 weeks thereafter.
- Being tested
- Intraocular anti-VEGF injection, SENSIMED Triggerfish
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular anti-VEGF injectionProcedure or surgery
SENSIMED TriggerfishDevice
| Study group | Role | What they receive |
|---|---|---|
| Anti-VEGF substance | Experimental | At the first study visit patients receive anti-VEGF injection with the standard substance (comparator) and at the second visit with an alternative anti-VEGF substance. Receives: Procedure: Intraocular anti-VEGF injection; Device: SENSIMED Triggerfish |
| Sclerotomy occlusion | Experimental | In the first session patients receive anti-VEGF injection without occlusion of the injection hole, while in the second session no occlusion is done. Receives: Procedure: Intraocular anti-VEGF injection; Device: SENSIMED Triggerfish |
| Injection volume | Experimental | In the first session patients receive anti-VEGF injection with the standard injection volume, while in the second session they receive anti-VEGF injection with a modified injection volume. Receives: Procedure: Intraocular anti-VEGF injection; Device: SENSIMED Triggerfish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak amplitude on SENSIMED Trggerfish (TF) pattern within 2 hours of injection
The TF output before injection will be compared to the TF peak value recorded within 2 hours of the anti-VEGF injection. The difference between these two values is the peak amplitude, expressed in mVeq (millivolt equivalent).
Measured: 2 hours after anti-VEGF injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age Related Macular Degeneration (AMD)Studies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roberto Gallego Pinazo, Principal investigator, Hospital Universitario y Politecnico La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983579
- Sponsor's protocol ID
- TF-1304
- Status last verified
- Nov 2015
- First submitted
- 24 Oct 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Label, Prospective Study Assessing the IOP (Intraocular Pressure) Patterns Using SENSIMED Triggerfish® in Association With Anti-VEGF Injection
- ClinicalTrials.gov ID
- NCT01983579
- Acronym / sponsor ID
- TF-1304
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Nov 2013 (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.
This is a prospective, open label study assessing the 24-hour IOP patterns using TF in patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related macular degeneration). The study will be proposed to patients with AMD and patients with AMD and concomitant open angle glaucoma (OAG).
The study will be conducted in two stages. In both stages, patients will remain ambulatory and will be encouraged to follow a schedule as close to their usual lifestyle as possible, with the exception of particular activities such as caffeine intake, playing wind instruments, yoga and strenuous exercise. A patient diary will be distributed for the capture of patient activities during the TF pattern recording. Upon completion of each session, the CLS (contact lens sensor) will be removed and a final ophthalmic examination will be conducted.
In the first stage of the study, 20 patients with neovascular AMD with an IOP in the normal range and no concomitant glaucoma will be recruited. After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. One eye will be selected for the study. If both eyes are eligible, the study eye will be selected in random manner.
All 20 AMD patients will receive two 24-hour recording sessions (S) with the TF CLS, at monthly interval. In the first session (S1) anti-VEGF injection will be carried out according to the study center standard protocol. For the second 24-hour TF recording session (S2), patients will be randomly distributed into three groups. Group A, consisting of 5 patients, will receive anti-VEGF injection with a different anti-VEGF substance as compared to S1. Group B, also consisting of 5 patients, will receive anti-VEGF without sclerotomy occlusion after injection as compared to S1. Finally, group C, including 10 patients, will receive anti-VEGF in a different dose (injection volume) as compared to S1. The randomization ratio between groups A, B and C is 1:1:2.
The overall study duration for an eligible patient in the first stage of this study is limited to 5 weeks.
If in the first stage of this study an injection protocol is identified that provokes significantly lesser elevation on the TF pattern, the alternative injection protocol will be evaluated against the current standard protocol. For the second stage, 30 patients of whom 15 with neovascular AMD and 15 with neovascular AMD and concomitant OAG will be recruited. After giving informed consent and confirmation of eligibility, all patients will receive two 24-hour TF CLS recording sessions (S3 and S4) at monthly interval, during which anti-VEGF injection according to the standard and alternative protocol will be carried out in random sequence.
The overall study duration for a patient in the second stage of the study is limited to 5 weeks.
The study has been planned to recruit 20 eligible patients in the first stage within 12 weeks from the date of initiation. The second stage will recruit 30 patients within 16 weeks. Hence the overall study duration from the first patient accrued into the study until last patient out equates to about 33 weeks. Allowing for a database lock within 4 weeks of study completion, a preliminary statistical report on the primary efficacy endpoint is foreseen within 2 weeks thereafter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-VEGF substance | Experimental | Procedure: Intraocular anti-VEGF injection, Device: SENSIMED TriggerfishAt the first study visit patients receive anti-VEGF injection with the standard substance (comparator) and at the second visit with an alternative anti-VEGF substance. |
| Sclerotomy occlusion | Experimental | Procedure: Intraocular anti-VEGF injection, Device: SENSIMED TriggerfishIn the first session patients receive anti-VEGF injection without occlusion of the injection hole, while in the second session no occlusion is done. |
| Injection volume | Experimental | Procedure: Intraocular anti-VEGF injection, Device: SENSIMED TriggerfishIn the first session patients receive anti-VEGF injection with the standard injection volume, while in the second session they receive anti-VEGF injection with a modified injection volume. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of neovascular AMD or neovascular AMD with concomitant OAG
- Aged ≥ 50 years
- Not more than 6 diopters spherical refraction equivalent in the study eye
- Having given written informed consent, prior to any investigational procedures
Key exclusion criteria (9 listed)
- Pigmentary glaucoma, exfoliative glaucoma, narrow or closed iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye
- History of ocular incision or laser surgery on the study eye (except cataract extraction)
- Corneal or conjunctival abnormality in the study eye precluding contact lens adaptation
- Severe dry eye syndrome
- Subjects with irregular sleep schedule or with sleep apnea syndrome
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 |
|---|---|---|
| Intraocular anti-VEGF injection | Procedure or surgery | Anti-VEGF substance, Injection volume, Sclerotomy occlusion |
| SENSIMED Triggerfish | Device | Anti-VEGF substance, Injection volume, Sclerotomy occlusion |
Primary outcome
Peak amplitude on SENSIMED Trggerfish (TF) pattern within 2 hours of injection
Time frame: 2 hours after anti-VEGF injection
The TF output before injection will be compared to the TF peak value recorded within 2 hours of the anti-VEGF injection. The difference between these two values is the peak amplitude, expressed in mVeq (millivolt equivalent).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Roberto Gallego Pinazo principal investigator
Hospital Universitario y Politecnico La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intraocular anti-VEGF injection and SENSIMED Triggerfish in people with Neovascular Age Related Macular Degeneration (AMD) and Open Angle Glaucoma, run by Sensimed AG at 1 site in Spain.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Nov 2015. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Peak amplitude on SENSIMED Trggerfish (TF) pattern within 2 hours of injection (time frame: 2 hours after anti-VEGF 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 17 Nov 2015.