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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prospective 1- Arm | Other | OCT-guided high frequency intravitreal ranibizumab 0.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreal injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 month OCT Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the correlation between activation of CNV evaluated by OCT (any fluid) and changes of BCVA. | â–º To evaluate the correlation between activation of CNV evaluated by OCT (any fluid) and changes of BCVA. | 12 month |
| To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on BCVA changes at month 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Pruente, MD | Vista Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vista Klinik | Binningen | 4102 | Switzerland |
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| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on BCVA changes at month 12. |
| 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. | 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. | 12 months |
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |