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

NCT01986907 | Completed Phase 4 Results

• 2 other identifiers: CRFB002AIT022013-003333-15
• Study Type: interventional
• Target: 1,049
• Locations: 1 country
• Sites: 101

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Systemic Drug-related Adverse Events

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

  Baseline to Month 12

• Number of Eyes With Ocular Drug-related Adverse Events

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

  Baseline to Month 12

Secondary Outcomes (3)

• Overall Number of Ranibizumab Injections

  Baseline to month 12

• Time Interval Between Injections in Bilateral Disease

  Baseline to month 12

• Mean Number of Injections Per Patient

  Baseline to month 12

Study Arms (1)

Ranibizumab

EXPERIMENTAL

Administered as an Intravitreal injection

Drug: ranibizumab

Interventions

ranibizumab DRUG

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).

Ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (101)

Novartis Investigative Site

Alessandria, AL, 15100, Italy

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Novartis Investigative Site

Casale Monferrato, AL, 15033, Italy

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Novartis Investigative Site

Ancona, AN, 60126, Italy

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Novartis Investigative Site

Acquaviva delle Fonti, BA, 70021, Italy

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Novartis Investigative Site

Putignano, BA, 70017, Italy

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Novartis Investigative Site

Terlizzi, BA, 70038, Italy

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Novartis Investigative Site

Bergamo, BG, 24127, Italy

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Novartis Investigative Site

Belluno, BL, 32100, Italy

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Novartis Investigative Site

Brescia, BS, 25123, Italy

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Novartis Investigative Site

Desenzano del Garda, BS, 25015, Italy

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Novartis Investigative Site

Bolzano, BZ, 39100, Italy

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Novartis Investigative Site

Cagliari, CA, 09124, Italy

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Novartis Investigative Site

Larino, CB, Italy

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Novartis Investigative Site

Caserta, CE, 81100, Italy

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Novartis Investigative Site

Chieti, CH, 66100, Italy

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Novartis Investigative Site

Ceva, CN, 12073, Italy

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Novartis Investigative Site

Cuneo, CN, 12100, Italy

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Novartis Investigative Site

Como, CO, 22100, Italy

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Novartis Investigative Site

San Feramo Della Battaglia, CO, 22020, Italy

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Novartis Investigative Site

Acireale, CT, 95024, Italy

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Novartis Investigative Site

Catania, CT, 95123, Italy

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Novartis Investigative Site

Catania, CT, 95124, Italy

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Novartis Investigative Site

Catanzaro, CZ, 88100, Italy

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Novartis Investigative Site

Forlì, FC, 47100, Italy

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Novartis Investigative Site

Cona, FE, 44100, Italy

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Novartis Investigative Site

Foggia, FG, 71100, Italy

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Novartis Investigative Site

San Giovanni Rotondo, FG, 71013, Italy

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Novartis Investigative Site

Genova, GE, 16132, Italy

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Novartis Investigative Site

Genova, GE, 16153, Italy

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Novartis Investigative Site

Rapallo, GE, 16035, Italy

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Novartis Investigative Site

Crotone, KR, 88074, Italy

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Novartis Investigative Site

Tricase, LE, 73039, Italy

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Novartis Investigative Site

Terracina, LT, 04019, Italy

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Novartis Investigative Site

Messina, ME, 98125, Italy

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Novartis Investigative Site

Milazzo, ME, 98057, Italy

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Novartis Investigative Site

Cinisello Balsamo, MI, 20092, Italy

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Novartis Investigative Site

Legnano, MI, 20025, Italy

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Novartis Investigative Site

Milan, MI, 20100, Italy

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Novartis Investigative Site

Milan, MI, 20122, Italy

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Novartis Investigative Site

Milan, MI, 20123, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Milan, MI, 20142, Italy

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Novartis Investigative Site

Rozzano, MI, 20089, Italy

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Novartis Investigative Site

Vizzolo Predabissi, MI, 20070, Italy

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Novartis Investigative Site

Nuoro, NU, 08100, Italy

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Novartis Investigative Site

Palermo, PA, 90127, Italy

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Novartis Investigative Site

Palermo, PA, 90146, Italy

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Novartis Investigative Site

Piacenza, PC, 29100, Italy

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Novartis Investigative Site

Camposampiero, PD, 35012, Italy

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Novartis Investigative Site

Monselice, PD, 35043, Italy

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Novartis Investigative Site

Padua, PD, 35100, Italy

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Novartis Investigative Site

Padua, PD, 35128, Italy

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Novartis Investigative Site

Pescara, PE, 65124, Italy

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Novartis Investigative Site

Città di Castello, PG, 06012, Italy

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Novartis Investigative Site

Foligno, PG, 06034, Italy

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Novartis Investigative Site

Perugia, PG, 06100, Italy

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Novartis Investigative Site

Pordenone, PN, 33170, Italy

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Novartis Investigative Site

Parma, PR, 43100, Italy

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Novartis Investigative Site

Pavia, PV, 27100, Italy

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Novartis Investigative Site

Reggio Calabria, RC, 89124, Italy

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Novartis Investigative Site

Correggio, RE, 42015, Italy

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Novartis Investigative Site

Reggio Emilia, RE, 42123, Italy

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Novartis Investigative Site

Civitavecchia, RM, 00053, Italy

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Novartis Investigative Site

Roma, RM, 00133, Italy

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Novartis Investigative Site

Roma, RM, 00161, Italy

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Novartis Investigative Site

Roma, RM, 00168, Italy

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Novartis Investigative Site

Roma, RM, 00184, Italy

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Novartis Investigative Site

Roma, RM, 00186, Italy

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Novartis Investigative Site

Roma, RM, 00189, Italy

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Novartis Investigative Site

Riccione, RN, 47838, Italy

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Novartis Investigative Site

Eboli, SA, 84025, Italy

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Novartis Investigative Site

Salerno, SA, 84131, Italy

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Novartis Investigative Site

Sondrio, SO, 23100, Italy

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Novartis Investigative Site

Sarzana, SP, 19038, Italy

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Novartis Investigative Site

Sassari, SS, 07100, Italy

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Novartis Investigative Site

Savona, SV, 17100, Italy

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Novartis Investigative Site

Taranto, TA, 74100, Italy

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Novartis Investigative Site

Teramo, TE, 64100, Italy

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Novartis Investigative Site

Torino, TO, 10122, Italy

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Novartis Investigative Site

Torino, TO, 10152, Italy

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Novartis Investigative Site

Torino, TO, 10153, Italy

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Novartis Investigative Site

Terni, TR, 05100, Italy

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Novartis Investigative Site

Trieste, TS, 34129, Italy

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Novartis Investigative Site

Conegliano, TV, 31015, Italy

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Novartis Investigative Site

Treviso, TV, 31100, Italy

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Novartis Investigative Site

Udine, UD, 33100, Italy

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Novartis Investigative Site

Busto Arsizio, VA, 21052, Italy

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Novartis Investigative Site

Somma Lombardo, VA, 21019, Italy

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Novartis Investigative Site

Varese, VA, 21100, Italy

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Novartis Investigative Site

Santorso, VI, 36014, Italy

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Novartis Investigative Site

Vicenza, VI, 36100, Italy

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Novartis Investigative Site

Legnago, VR, 37045, Italy

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Novartis Investigative Site

Negrar, VR, 37024, Italy

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Novartis Investigative Site

Verona, VR, 37126, Italy

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Novartis Investigative Site

Borgomanero, 28021, Italy

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Novartis Investigative Site

Galliate, 28066, Italy

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Novartis Investigative Site

Napoli, 80131, Italy

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Novartis Investigative Site

Napoli, 80132, Italy

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Novartis Investigative Site

Napoli, 80138, Italy

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Novartis Investigative Site

Pozzuoli, 80078, Italy

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MeSH Terms

Conditions

Macular Degeneration; Retinal Diseases; Eye Diseases

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

+41613241111

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: March 4, 2014
• Primary Completion: June 15, 2016
• Study Completion: June 15, 2016
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Locations

IT (101)