Choroidal NeovascularizationPhase 4NCT03393767
Time Course of Activity Signs at SD-OCT High Frequency Intravitreal Ranibizumab Treatment in CNV Due to AMD
A Phase 4 study testing Ranibizumab in people with Choroidal Neovascularization and Age Related Macular Degeneration, run by Vista Klinik at 1 site in Switzerland.
Trial summary
The purpose of the study is to detect persisting or early new activity of choroidal neovascularization (CNV) due to age related macular degeneration (AMD) during the first 12 months following the first ranibizumab dose at baseline as assessed by weekly high resolution optical coherence tomography (OCT). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Choroidal Neovascularization, Age Related Macular Degeneration
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2010to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 50 years of age.
- Patients with active primary subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
- Evidence that CNV extends under the geometric center of the foveal avascular zone.
- Total CNV area encompassed within the lesion must be ≥ 50% of total lesion area.
- The total lesion area ≤ 12 disc areas for minimally classic or occult with no classic component and ≤ 9 disc areas (5400µm) in greatest linear dimension with predominantly classic lesions.
- Patients who have a BCVA of 20/32 to 20/320 (letter score of 78 to 25 letters) in the study eye using ETDRS charts.
- Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure.
- Willing and able to comply with study procedures.
Who cannot join
- Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1 disc area in size.
- Structural damage to the center of the macula (beside CNV) in the study eye.
- Presence of a retinal pigment epithelial tear involving the macula in the study eye.
- Patients with angioid streaks or precursors of CNV in either eye due to other causes.
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
- Vitreous hemorrhage, history of rhegmatogenous retinal detachment or macular hole.
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- Active intraocular inflammation (grade trace or above) in the study eye.
- Any active infection involving ocular adnexa.
- History of uncontrolled glaucoma in the study eye.
- Aphakia with absence of the posterior capsule in the study eye.
- Any prior treatment in the study eye with verteporfin, subfoveal focal laser photo-coagulation, vitrectomy, transpupillary thermotherapy, intravitreally applied drugs.
- History of submacular surgery or other surgical intervention for AMD in the study eye.
- Extracapsular extraction of cataract within 3 months preceding Baseline.
- Previous violation of posterior capsule in the study eye (unless YAG capsulotomy).
- History of Stroke.
- Pregnant or nursing (lactating) women.
- History of hypersensitivity or allergy to fluorescein.
- Inability to obtain OCT/photographs/fluorescein angiograms of sufficient quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Course of Activity Signs at High Resolution OCT During OCT-guided High Frequency Intravitreal Ranibizumab Treatment in Choroidal Neovascularization Due to Age Related Macular Degeneration
The purpose of the study is to detect persisting or early new activity of choroidal neovascularization (CNV) due to age related macular degeneration (AMD) during the first 12 months following the first ranibizumab dose at baseline as assessed by weekly high resolution optical coherence tomography (OCT). Detection of persisting or new signs of CNV activity at OCT triggers further ranibizumab treatments considering that any ranibizumab injections can maximally be applied as often as 2-weekly.
Read the detailed description
This is a prospective, 1-arm, monocenter study designed to evaluate the time course of early re-activation of CNV assessed by High Resolution OCT. An OCT-guided high frequency (up to 2-weekly) intravitreal ranibizumab treatment in CNV due to AMD may prevent further growth and early re-growth of CNV as evaluated by OCT at a weekly basis.
Consenting, enrolled patients will receive one 0.5 mg ranibizumab intravitreal injection at baseline (month 0). Afterwards all patients will undergo a weekly OCT assessment. Further treatments, which can maximally be applied as often as 2-weekly, are triggered by persisting or new signs of CNV activity at OCT as defined by intraretinal cysts or subretinal fluid. For this study, a month is defined as 28 days, a 2-week period as 14 days. During the 12-month study period, a maximum of 24 ranibizumab injections may be administered.
An interim analysis will not be performed. The study will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).
- Being tested
- Ranibizumab
- Keywords
- CNV, AMD, ranibizumab
- Medical subject headings
- Choroidal Neovascularization, 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
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| prospective 1- Arm | Other | OCT-guided high frequency intravitreal ranibizumab 0.5mg Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CNV activity (any fluid) as assessed by High Resolution OCT
The primary objective is to evaluate the time course of early re-activation of CNV assessed by High Resolution OCT.
Measured: 12 month OCT Assessment
Secondary outcomes (4)
To evaluate the correlation between activation of CNV evaluated by OCT (any fluid) and changes of BCVA.
► To evaluate the correlation between activation of CNV evaluated by OCT (any fluid) and changes of BCVA.
Measured: 12 month
To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on BCVA changes at month 12.
To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on BCVA changes at month 12.
Measured: 12 months
To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on the total number of injections needed within the 12 months observation period.
To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on the total number of injections needed within the 12 months observation period.
Measured: 12 months
To evaluate the safety and tolerability of up to 2-weekly dosing of ranibizumab by determining the rates of adverse events and serious adverse events at month 12.
To evaluate the safety and tolerability of up to 2-weekly dosing of ranibizumab by determining the rates of adverse events and serious adverse events at month 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study startDec 2010
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vista Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Katja Hatz, Vista Klinik
- Investigators
- Christian Pruente, MD, Principal investigator, Vista Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393767
- Sponsor's protocol ID
- OCT-2010-07
- Status last verified
- Jan 2018
- First submitted
- 26 Nov 2014
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of Activity Signs at High Resolution OCT During OCT-guided High Frequency Intravitreal Ranibizumab Treatment in Choroidal Neovascularization Due to Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03393767
- Acronym / sponsor ID
- OCT-2010-07
- Keywords
- CNV, AMD, ranibizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vista KlinikUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Jan 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 purpose of the study is to detect persisting or early new activity of choroidal neovascularization (CNV) due to age related macular degeneration (AMD) during the first 12 months following the first ranibizumab dose at baseline as assessed by weekly high resolution optical coherence tomography (OCT). Detection of persisting or new signs of CNV activity at OCT triggers further ranibizumab treatments considering that any ranibizumab injections can maximally be applied as often as 2-weekly.
Detailed description
This is a prospective, 1-arm, monocenter study designed to evaluate the time course of early re-activation of CNV assessed by High Resolution OCT. An OCT-guided high frequency (up to 2-weekly) intravitreal ranibizumab treatment in CNV due to AMD may prevent further growth and early re-growth of CNV as evaluated by OCT at a weekly basis.
Consenting, enrolled patients will receive one 0.5 mg ranibizumab intravitreal injection at baseline (month 0). Afterwards all patients will undergo a weekly OCT assessment. Further treatments, which can maximally be applied as often as 2-weekly, are triggered by persisting or new signs of CNV activity at OCT as defined by intraretinal cysts or subretinal fluid. For this study, a month is defined as 28 days, a 2-week period as 14 days. During the 12-month study period, a maximum of 24 ranibizumab injections may be administered.
An interim analysis will not be performed. The study will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prospective 1- Arm | Other | Drug: RanibizumabOCT-guided high frequency intravitreal ranibizumab 0.5mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients ≥ 50 years of age.
- Patients with active primary subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
- Evidence that CNV extends under the geometric center of the foveal avascular zone.
- Total CNV area encompassed within the lesion must be ≥ 50% of total lesion area.
- The total lesion area ≤ 12 disc areas for minimally classic or occult with no classic component and ≤ 9 disc areas (5400µm) in greatest linear dimension with predominantly classic lesions.
Key exclusion criteria (18 listed)
- Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1 disc area in size.
- Structural damage to the center of the macula (beside CNV) in the study eye.
- Presence of a retinal pigment epithelial tear involving the macula in the study eye.
- Patients with angioid streaks or precursors of CNV in either eye due to other causes.
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
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: LucentisIntravitreal injection | Drug | prospective 1- Arm |
Primary outcome
Change in CNV activity (any fluid) as assessed by High Resolution OCT
Time frame: 12 month OCT Assessment
The primary objective is to evaluate the time course of early re-activation of CNV assessed by High Resolution OCT.
4 secondary outcomes
To evaluate the correlation between activation of CNV evaluated by OCT (any fluid) and changes of BCVA.
Time frame: 12 month
To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on BCVA changes at month 12.
Time frame: 12 months
To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on the total number of injections needed within the 12 months observation period.
Time frame: 12 months
To evaluate the safety and tolerability of up to 2-weekly dosing of ranibizumab by determining the rates of adverse events and serious adverse events at month 12.
Time frame: 12 months
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 8 Jan 2018.
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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.
Christian Pruente, MD principal investigator
Vista Klinik
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 Ranibizumab in people with Choroidal Neovascularization and Age Related Macular Degeneration, run by Vista Klinik at 1 site in Switzerland.
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 8 inclusion and 18 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 8 Jan 2018. 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 Switzerland. 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 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?
Change in CNV activity (any fluid) as assessed by High Resolution OCT (time frame: 12 month OCT Assessment). 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 8 Jan 2018.