Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD

NCT01948830 | Completed Phase 3 Results

• 2 other identifiers: CRFB002A24112013-002626-23
• Study Type: interventional
• Target: 650
• Locations: 18 countries
• Sites: 86

Brief Summary

This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration

Conditions

Age-related Macular Degeneration; Choroidal Neovascularization

Keywords

Ranibizumab, Lucentis, choroidal neovascularization, age-related macular degeneration, treat and extend regimen

Outcome Measures

Primary Outcomes (1)

• Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12

  Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement

  Baseline to month 12

Secondary Outcomes (13)

• Number of Visits Scheduled

  From Month1 to Month 11

• Change in BCVA From Baseline to Month 12

  Baseline to Month 12

• Average BCVA Change From Baseline to Month 12

  Baseline and every month for 12 months

• Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12

  Baseline and every month for 12 months

• Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12

  Baseline and every month for 12 months

Study Arms (2)

Group I ranibizumab 0.5 mg monthly

ACTIVE COMPARATOR

Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) up to month 11

Drug: Ranibizumab 0.5mg

Group II ranibizumab 0.5 mg TER

ACTIVE COMPARATOR

Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen up to month 11

Drug: Ranibizumab 0.5mg

Interventions

Ranibizumab 0.5mg DRUG

0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

Also known as: Lucentis

Group I ranibizumab 0.5 mg monthly

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, ≥50 years of age with signed informed consent before study procedures
• Visual impairment predominantly due to nAMD.
• Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography
• Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT
• BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320)

You may not qualify if:

• Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
• Stroke or myocardial infarction within 3 months prior to Screening.
• Any active periocular or ocular infection or inflammation in both eyes.
• Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity.
• Presence of amblyopia or amaurosis in the fellow eye.
• History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab \[Avastin®\], aflibercept \[Eylea®\]) or vPDT in the study eye.
• History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening.
• Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (91)

Novartis Investigative Site

Antwerp, 2020, Belgium

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Ottignies, 1340, Belgium

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Zottegem, 9620, Belgium

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Santiago, 7650018, Chile

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Zagreb, Croatia, 10000, Croatia

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Glostrup Municipality, 2600, Denmark

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Roskilde, 4000, Denmark

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Cairo, Abbassia, Egypt

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Cairo, Egypt

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Leipzig, Germany, 04103, Germany

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Ahaus, 48683, Germany

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Augsburg, 86156, Germany

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Chemnitz, 09113, Germany

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Cologne, 50935, Germany

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Darmstadt, 64297, Germany

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Göttingen, 37075, Germany

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Hanover, 30625, Germany

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Karlsruhe, 76199, Germany

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Ludwigshafen, 67063, Germany

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Magdeburg, 39120, Germany

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Münster, 48145, Germany

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Münster, 48149, Germany

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Siegburg, 53721, Germany

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Stuttgart, 70174, Germany

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Sulzbach, 66280, Germany

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Budapest, 1076, Hungary

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Budapest, 1083, Hungary

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Budapest, 1106, Hungary

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Budapest, 1133, Hungary

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Budapest, 1145, Hungary

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Budapest, H-1115, Hungary

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Debrecen, 4012, Hungary

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Pécs, 7624, Hungary

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Szeged, H-6725, Hungary

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Zalaegerszeg, 8900, Hungary

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Bangalore, Karnataka, 560010, India

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Chennai, Tamil Nadu, 600 006, India

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Vanchiyoor, Thiruvanantapuram, 695035, India

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Haifa, 3525408, Israel

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Jerusalem, 9112001, Israel

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Petah Tikva, 49100, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 6423906, Israel

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Florence, FI, 50134, Italy

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Milan, MI, 20100, Italy

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Milan, MI, 20132, Italy

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Padua, PD, 35128, Italy

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Pisa, PI, 56124, Italy

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Roma, RM, 00198, Italy

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Sassari, SS, 07100, Italy

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Udine, UD, 33100, Italy

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Coimbra, Portugal, 3000-354, Portugal

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Coimbra, Portugal, 3030-163, Portugal

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Lisbon, Portugal, 1150-314, Portugal

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Porto, Portugal, 4099-001, Portugal

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Vila Franca de Xira, Portugal, 2600-009, Portugal

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Kazan', 420012, Russia

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Moscow, 119021, Russia

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Moscow, 127486, Russia

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Novosibirsk, 630071, Russia

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Samara, 443068, Russia

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Banská Bystrica, Slovakia, 97517, Slovakia

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Nové Zámky, Slovakia, 94001, Slovakia

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Poprad, Slovakia, 05845, Slovakia

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Žilina, Slovakia, 01207, Slovakia

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Bratislava, 82606, Slovakia

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Ljubljana, Slovenia, 1000, Slovenia

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Busan, Busan, 49241, South Korea

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Seongnam-si, Gyeonggi-do, 13620, South Korea

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Seoul, Korea, 03080, South Korea

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Seoul, Korea, 06591, South Korea

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Barcelona, Barcelona, 08025, Spain

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Valladolid, Castille and León, 47011, Spain

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Barcelona, Catalonia, 08022, Spain

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Sant Cugat del Vallès, Catalonia, 08190, Spain

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Oviedo, Principality of Asturias, 33012, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Bern, 3010, Switzerland

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Bern, 3012, Switzerland

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Lausanne, 1007, Switzerland

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Zurich, 8063, Switzerland

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Ankara, Turkey, 06490, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Uxbridge, London, UB8 3NN, United Kingdom

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Frimley, Surrey, GU16 7UJ, United Kingdom

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Belfast, BT12 6BA, United Kingdom

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Bristol, BS1 2LX, United Kingdom

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Guildford, Surrey, GU2 5XX, United Kingdom

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London, EC1V 2PD, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Sunderland, SR2 9HP, United Kingdom

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Related Publications (3)

• Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.

  PMID: 34934034 DERIVED

• Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.

  PMID: 32374423 DERIVED

• Waldstein SM, Coulibaly L, Riedl S, Sadeghipour A, Gerendas BS, Schmidt-Erfurth UM. Effect of posterior vitreous detachment on treat-and-extend versus monthly ranibizumab for neovascular age-related macular degeneration. Br J Ophthalmol. 2020 Jul;104(7):899-903. doi: 10.1136/bjophthalmol-2019-314661. Epub 2019 Sep 28.

  PMID: 31563866 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

862-778-8300

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 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 24, 2013
• Study Start: December 17, 2013
• Primary Completion: November 19, 2015
• Study Completion: November 19, 2015
• Last Updated: April 17, 2017
• Results First Posted: December 15, 2016

Record last verified: 2017-03

Locations

DE (16); ES (6); CH (4); IT (8); GB (8); DK (2); TU (2); CL (1); IL (5); SL (1); CR (1); IN (3); EG (2); RU (5); PT (5); KR (4); HU (10); BE (3)