Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 3:57 PM
Study NCT ID:
NCT03409250
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2014-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SD-OCT-guided Intravitreal Ranibizumab Treatment in Choroidal Neovascularization Due to Myopia
Sponsor:
Vista Klinik
Organization:
Study Overview
Official Title:
SD-OCT-guided Intravitreal Ranibizumab Treatment in Choroidal Neovascularization Due to Myopia
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This investigator initiated pilot study is designed to investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of Ranibizumab 0.5mg (Lucentis) at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral-domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
Detailed Description:
Study purpose: This investigator iniiated pilot study is designed to investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of Ranibizumab 0.5mg (Lucentis) at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral-domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
Objectives: To investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia.
The primary objective is to demonstrate that a SD-OCT-guided intravitreal ranibizumab treatment in CNV due to myopia may prevent vision loss as evaluated as change in BCVA from baseline.
The secondary objectives are:
* To evaluate the changes in BCVA at 6 and 12 months compared to baseline.
* To evaluate the number of treatments needed at 6 and 12 months and the time course of re-treatments.
* To evaluate the time course of re-activation of CNV as evaluated by High Resolution OCT.
* To evaluate the incidence of fluorescein leakage as well as the mean and percent change in total area of CNV, total area of leakage from CNV, and total lesion area at 6 and 12 months.
* To evaluate the safety and tolerability of up to monthly dosing of ranibizumab in CNV due to myopia by determining the rates of adverse events and serious adverse events at month 6 and 12.
Population: This outpatient study population will consist of a representative group of male and female patients ≥ 18 years of age. The study population will include patients with newly diagnosed and active choroidal neovascularization (CNV) due to myopia. 20 Patients will be enrolled in one study center (Vista Klinik, Binningen).
Investigational and reference therapy:
This study will include the following study drug:
• Ranibizumab (Lucentis®) 0.5 mg for intravitreal injection.
Study design: This is a prospective, 1-arm, monocenter, investigator initiated study designed to evaluate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of ranibizumab 0.5mg at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT, as defined by intraretinal cysts or subretinal fluid, triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
For this study, a month is defined as 28 days. During the 12-month study period, a maximum of 12 ranibizumab injections may be administered.
Objectives: To investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia.
The primary objective is to demonstrate that a SD-OCT-guided intravitreal ranibizumab treatment in CNV due to myopia may prevent vision loss as evaluated as change in BCVA from baseline.
The secondary objectives are:
* To evaluate the changes in BCVA at 6 and 12 months compared to baseline.
* To evaluate the number of treatments needed at 6 and 12 months and the time course of re-treatments.
* To evaluate the time course of re-activation of CNV as evaluated by High Resolution OCT.
* To evaluate the incidence of fluorescein leakage as well as the mean and percent change in total area of CNV, total area of leakage from CNV, and total lesion area at 6 and 12 months.
* To evaluate the safety and tolerability of up to monthly dosing of ranibizumab in CNV due to myopia by determining the rates of adverse events and serious adverse events at month 6 and 12.
Population: This outpatient study population will consist of a representative group of male and female patients ≥ 18 years of age. The study population will include patients with newly diagnosed and active choroidal neovascularization (CNV) due to myopia. 20 Patients will be enrolled in one study center (Vista Klinik, Binningen).
Investigational and reference therapy:
This study will include the following study drug:
• Ranibizumab (Lucentis®) 0.5 mg for intravitreal injection.
Study design: This is a prospective, 1-arm, monocenter, investigator initiated study designed to evaluate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of ranibizumab 0.5mg at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT, as defined by intraretinal cysts or subretinal fluid, triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
For this study, a month is defined as 28 days. During the 12-month study period, a maximum of 12 ranibizumab injections may be administered.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: