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Time Course of Activity Signs at SD-OCT High Frequency Intravitreal Ranibizumab Treatment in CNV Due to AMD

Primary Purpose

Choroidal Neovascularization, Age Related Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Ranibizumab

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring CNV, AMD, ranibizumab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Vista Klinik

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

prospective 1- Arm

Arm Description

OCT-guided high frequency intravitreal ranibizumab 0.5mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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 the total number of injections needed within the 12 months observation period.

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.

Full Information

NCT ID

NCT03393767

First Posted

November 26, 2014

Last Updated

January 2, 2018

Sponsor

Vista Klinik

1. Study Identification

Unique Protocol Identification Number

NCT03393767

Brief Title

Time Course of Activity Signs at SD-OCT High Frequency Intravitreal Ranibizumab Treatment in CNV Due to AMD

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vista Klinik

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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). 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choroidal Neovascularization, Age Related Macular Degeneration

Keywords

CNV, AMD, ranibizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

prospective 1- Arm

Arm Type

Other

Arm Description

OCT-guided high frequency intravitreal ranibizumab 0.5mg

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

Intravitreal injection

Primary Outcome Measure Information:

Title

Change in CNV activity (any fluid) as assessed by High Resolution OCT

Description

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

Secondary Outcome Measure Information:

Title

To evaluate the correlation between activation of CNV evaluated by OCT (any fluid) and changes of BCVA.

Description

► To evaluate the correlation between activation of CNV evaluated by OCT (any fluid) and changes of BCVA.

Time Frame

12 month

Title

To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on BCVA changes at month 12.

Description

To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on BCVA changes at month 12.

Time Frame

12 months

Title

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.

Description

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

Title

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.

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Pruente, MD

Organizational Affiliation

Vista Klinik

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vista Klinik

City

Binningen

ZIP/Postal Code

4102

Country

Switzerland

12. IPD Sharing Statement

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Time Course of Activity Signs at SD-OCT High Frequency Intravitreal Ranibizumab Treatment in CNV Due to AMD

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