A Phase 4 interventional study of Ranibizumab in Choroidal Neovascularization and Age Related Macular Degeneration, sponsored by Vista Klinik. Completed at 1 site in Switzerland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by Vista Klinik · Phase 4, Interventional, and Treatment
Among 45 studies testing ranibizumab in Choroidal Neovascularization — none open to participants now, none under way, none of them phase 3. Ranibizumab · Choroidal Neovascularization.
Among the 45 studies testing ranibizumab in Choroidal Neovascularization, this one is the 36th largest by enrollment, is one of 5 that started in 2010, is one of 12 in phase 4, and was the 42nd registered.
214 studies on the registry are indexed under Choroidal Neovascularization; 12 are open to participants now.
Browse Choroidal Neovascularization studies →None of the 45 studies testing ranibizumab in Choroidal Neovascularization is open now.
Ranibizumab: first FDA approval 2006 (LUCENTIS), first EMA approval 2007. What it is approved for, and how studies give it, is on its page →
Of the 6 Choroidal Neovascularization studies recruiting now, 4 (67%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 15 · Phase 3 12 · Phase 4 12
First in 2005; this study’s year is marked. 5 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 56 across 160 interventional studies indexed under Choroidal Neovascularization.
Median enrollment 62 across the 45 interventional studies. Of the 44 that completed or were terminated, 23 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 45 have an industry lead sponsor. The 10 most frequent:
Vista Klinik is the lead sponsor of 7 studies on the registry; none are open to participants now.
Vista Klinik has 2 studies filed under Choroidal Neovascularization — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 45 studies testing ranibizumab in Choroidal Neovascularization, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
OCT-guided high frequency intravitreal ranibizumab 0.5mg
Drug: Ranibizumab
Intravitreal injection
Also known as: Lucentis
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.
Time frame: 12 month OCT Assessment
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.
Time frame: 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.
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.
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.
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
The record gives a start of Dec 2010, a primary completion of Oct 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ranibizumab
Choroidal Neovascularization →
Vista Klinik