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Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye (TWEYES)

Primary Purpose

Wet Age Related Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

ranibizumab

About this trial

This is an interventional treatment trial for Wet Age Related Macular Degeneration focused on measuring wet AMD, macular degeneration, ranibizumab, mono-bilateral, poor visual acuity, retinal disease, eye disease, Angiogenesis Inhibitors, Angiogenesis Modulating Agents

Eligibility Criteria

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

Inclusion Criteria

Male or female patients aged 50 years or above Willing and capable to provide informed written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab

Exclusion Criteria:

Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab

Arm Description

Administered as an Intravitreal injection

Outcomes

Primary Outcome Measures

Number of Participants With Systemic Drug-related Adverse Events

Monitoring and recording all adverse events, including serious adverse events.

Number of Eyes With Ocular Drug-related Adverse Events

Monitoring and recording all adverse events, including serious adverse events.

Secondary Outcome Measures

Overall Number of Ranibizumab Injections

Time Interval Between Injections in Bilateral Disease

Mean number of days between two consecutive injections per eye

Mean Number of Injections Per Patient

Number of injections per patient

Full Information

NCT ID

NCT01986907

First Posted

November 12, 2013

Last Updated

May 11, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01986907

Brief Title

Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye

Acronym

TWEYES

Official Title

A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

March 4, 2014 (Actual)

Primary Completion Date

June 15, 2016 (Actual)

Study Completion Date

June 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).

6. Conditions and Keywords

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

Wet Age Related Macular Degeneration

Keywords

wet AMD, macular degeneration, ranibizumab, mono-bilateral, poor visual acuity, retinal disease, eye disease, Angiogenesis Inhibitors, Angiogenesis Modulating Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1049 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab

Arm Type

Experimental

Arm Description

Administered as an Intravitreal injection

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Intervention Description

All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).

Primary Outcome Measure Information:

Title

Number of Participants With Systemic Drug-related Adverse Events

Description

Monitoring and recording all adverse events, including serious adverse events.

Time Frame

Baseline to Month 12

Title

Number of Eyes With Ocular Drug-related Adverse Events

Description

Monitoring and recording all adverse events, including serious adverse events.

Time Frame

Baseline to Month 12

Secondary Outcome Measure Information:

Title

Overall Number of Ranibizumab Injections

Time Frame

Baseline to month 12

Title

Time Interval Between Injections in Bilateral Disease

Description

Mean number of days between two consecutive injections per eye

Time Frame

Baseline to month 12

Title

Mean Number of Injections Per Patient

Description

Number of injections per patient

Time Frame

Baseline to month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Male or female patients aged 50 years or above Willing and capable to provide informed written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab Exclusion Criteria: Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Alessandria

State/Province

ZIP/Postal Code

15100

Country

Italy

Facility Name

Novartis Investigative Site

City

Casale Monferrato

State/Province

ZIP/Postal Code

15033

Country

Italy

Facility Name

Novartis Investigative Site

City

Ancona

State/Province

ZIP/Postal Code

60126

Country

Italy

Facility Name

Novartis Investigative Site

City

Acquaviva delle Fonti

State/Province

ZIP/Postal Code

70021

Country

Italy

Facility Name

Novartis Investigative Site

City

Putignano

State/Province

ZIP/Postal Code

70017

Country

Italy

Facility Name

Novartis Investigative Site

City

Terlizzi

State/Province

ZIP/Postal Code

70038

Country

Italy

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novartis Investigative Site

City

Belluno

State/Province

ZIP/Postal Code

32100

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Desenzano del Garda

State/Province

ZIP/Postal Code

25015

Country

Italy

Facility Name

Novartis Investigative Site

City

Bolzano

State/Province

ZIP/Postal Code

39100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09124

Country

Italy

Facility Name

Novartis Investigative Site

City

Larino

State/Province

Country

Italy

Facility Name

Novartis Investigative Site

City

Caserta

State/Province

ZIP/Postal Code

81100

Country

Italy

Facility Name

Novartis Investigative Site

City

Chieti

State/Province

ZIP/Postal Code

66100

Country

Italy

Facility Name

Novartis Investigative Site

City

Ceva

State/Province

ZIP/Postal Code

12073

Country

Italy

Facility Name

Novartis Investigative Site

City

Cuneo

State/Province

ZIP/Postal Code

12100

Country

Italy

Facility Name

Novartis Investigative Site

City

Como

State/Province

ZIP/Postal Code

22100

Country

Italy

Facility Name

Novartis Investigative Site

City

San Feramo Della Battaglia

State/Province

ZIP/Postal Code

22020

Country

Italy

Facility Name

Novartis Investigative Site

City

Acireale

State/Province

ZIP/Postal Code

95024

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95123

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95124

Country

Italy

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Novartis Investigative Site

City

Catanzaro

State/Province

ZIP/Postal Code

88100

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Italy

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Novartis Investigative Site

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Forlì

State/Province

ZIP/Postal Code

47100

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Italy

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Novartis Investigative Site

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Cona

State/Province

ZIP/Postal Code

44100

Country

Italy

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Novartis Investigative Site

City

Foggia

State/Province

ZIP/Postal Code

71100

Country

Italy

Facility Name

Novartis Investigative Site

City

San Giovanni Rotondo

State/Province

ZIP/Postal Code

71013

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16153

Country

Italy

Facility Name

Novartis Investigative Site

City

Rapallo

State/Province

ZIP/Postal Code

16035

Country

Italy

Facility Name

Novartis Investigative Site

City

Crotone

State/Province

ZIP/Postal Code

88074

Country

Italy

Facility Name

Novartis Investigative Site

City

Tricase

State/Province

ZIP/Postal Code

73039

Country

Italy

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Novartis Investigative Site

City

Terracina

State/Province

ZIP/Postal Code

04019

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Italy

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Novartis Investigative Site

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Messina

State/Province

ZIP/Postal Code

98125

Country

Italy

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Novartis Investigative Site

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Milazzo

State/Province

ZIP/Postal Code

98057

Country

Italy

Facility Name

Novartis Investigative Site

City

Cinisello Balsamo

State/Province

ZIP/Postal Code

20092

Country

Italy

Facility Name

Novartis Investigative Site

City

Legnano

State/Province

ZIP/Postal Code

20025

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20100

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20123

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20142

Country

Italy

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Vizzolo Predabissi

State/Province

ZIP/Postal Code

20070

Country

Italy

Facility Name

Novartis Investigative Site

City

Nuoro

State/Province

ZIP/Postal Code

08100

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

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Novartis Investigative Site

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Piacenza

State/Province

ZIP/Postal Code

29100

Country

Italy

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Novartis Investigative Site

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Camposampiero

State/Province

ZIP/Postal Code

35012

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Italy

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Novartis Investigative Site

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Monselice

State/Province

ZIP/Postal Code

35043

Country

Italy

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Novartis Investigative Site

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Padova

State/Province

ZIP/Postal Code

35100

Country

Italy

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Novartis Investigative Site

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Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

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Novartis Investigative Site

City

Pescara

State/Province

ZIP/Postal Code

65124

Country

Italy

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Novartis Investigative Site

City

Citta' di Castello

State/Province

ZIP/Postal Code

06012

Country

Italy

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Novartis Investigative Site

City

Foligno

State/Province

ZIP/Postal Code

06034

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

State/Province

ZIP/Postal Code

06100

Country

Italy

Facility Name

Novartis Investigative Site

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Pordenone

State/Province

ZIP/Postal Code

33170

Country

Italy

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Novartis Investigative Site

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Parma

State/Province

ZIP/Postal Code

43100

Country

Italy

Facility Name

Novartis Investigative Site

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Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Calabria

State/Province

ZIP/Postal Code

89124

Country

Italy

Facility Name

Novartis Investigative Site

City

Correggio

State/Province

ZIP/Postal Code

42015

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Emilia

State/Province

ZIP/Postal Code

42123

Country

Italy

Facility Name

Novartis Investigative Site

City

Civitavecchia

State/Province

ZIP/Postal Code

00053

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00184

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00186

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00189

Country

Italy

Facility Name

Novartis Investigative Site

City

Riccione

State/Province

ZIP/Postal Code

47838

Country

Italy

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Novartis Investigative Site

City

Eboli

State/Province

ZIP/Postal Code

84025

Country

Italy

Facility Name

Novartis Investigative Site

City

Salerno

State/Province

ZIP/Postal Code

84131

Country

Italy

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Novartis Investigative Site

City

Sondrio

State/Province

ZIP/Postal Code

23100

Country

Italy

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Novartis Investigative Site

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Sarzana

State/Province

ZIP/Postal Code

19038

Country

Italy

Facility Name

Novartis Investigative Site

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Sassari

State/Province

ZIP/Postal Code

07100

Country

Italy

Facility Name

Novartis Investigative Site

City

Savona

State/Province

ZIP/Postal Code

17100

Country

Italy

Facility Name

Novartis Investigative Site

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Taranto

State/Province

ZIP/Postal Code

74100

Country

Italy

Facility Name

Novartis Investigative Site

City

Teramo

State/Province

ZIP/Postal Code

64100

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10122

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10152

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10153

Country

Italy

Facility Name

Novartis Investigative Site

City

Terni

State/Province

ZIP/Postal Code

05100

Country

Italy

Facility Name

Novartis Investigative Site

City

Trieste

State/Province

ZIP/Postal Code

34129

Country

Italy

Facility Name

Novartis Investigative Site

City

Conegliano

State/Province

ZIP/Postal Code

31015

Country

Italy

Facility Name

Novartis Investigative Site

City

Treviso

State/Province

ZIP/Postal Code

31100

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Busto Arsizio

State/Province

ZIP/Postal Code

21052

Country

Italy

Facility Name

Novartis Investigative Site

City

Somma Lombardo

State/Province

ZIP/Postal Code

21019

Country

Italy

Facility Name

Novartis Investigative Site

City

Varese

State/Province

ZIP/Postal Code

21100

Country

Italy

Facility Name

Novartis Investigative Site

City

Santorso

State/Province

ZIP/Postal Code

36014

Country

Italy

Facility Name

Novartis Investigative Site

City

Vicenza

State/Province

ZIP/Postal Code

36100

Country

Italy

Facility Name

Novartis Investigative Site

City

Legnago

State/Province

ZIP/Postal Code

37045

Country

Italy

Facility Name

Novartis Investigative Site

City

Negrar

State/Province

ZIP/Postal Code

37024

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37126

Country

Italy

Facility Name

Novartis Investigative Site

City

Borgomanero

ZIP/Postal Code

28021

Country

Italy

Facility Name

Novartis Investigative Site

City

Galliate

ZIP/Postal Code

28066

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80132

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Novartis Investigative Site

City

Pozzuoli

ZIP/Postal Code

80078

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye

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Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye (TWEYES)

Wet Age Related Macular Degeneration

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial