An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

NCT01908816 | Completed Phase 3 Results

• 1 other identifier: CRFB002GFR02
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 39

Brief Summary

The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Conditions

Choroidal Neovascularization; Macular Edema; Glaucoma, Neovascular; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.

  24 months

Secondary Outcomes (6)

• Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)

  3 months, 12 months

• Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma

  3 month, 12 month

• Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy

  3 months, 12 month

• Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"

  3 months, 12 month

• Proportion of Patients With Angiographic Leakage

  3 months, 12 month

Study Arms (1)

ranibizumab

EXPERIMENTAL

0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.

Drug: ranibizumab

Interventions

ranibizumab DRUG

One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)

ranibizumab

Eligibility Criteria

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

You may qualify if:

• Active choroidal neovascularization (CNV)
• Active macular edema (ME)
• Rubeosis iridis/neovascular glaucoma.
• Proliferative diabetic retinopathy requiring vitrectomy.

You may not qualify if:

• wet Age-related macular degeneration
• pathologic myopia
• pseudoxanthoma elasticum
• diabetic macular edema
• retinal vein occlusion
• \< 18 years of age
• History of hypersensitivity to ranibizumab
• Women of child-bearing potential and Pregnant or nursing (lactating) women.
• Active or suspected ocular infection

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (39)

Novartis Investigative Site

Bobigny, Seine Saint Denis, 93009, France

Location

Novartis Investigative Site

Amiens, 80054, France

Location

Novartis Investigative Site

Angers, 49044, France

Location

Novartis Investigative Site

Bordeaux, 33000, France

Location

Novartis Investigative Site

Bordeaux, 33100, France

Location

Novartis Investigative Site

Caen, 14050, France

Location

Novartis Investigative Site

Créteil, 94000, France

Location

Novartis Investigative Site

Écully, 69130, France

Location

Novartis Investigative Site

Grenoble, 38000, France

Location

Novartis Investigative Site

Grenoble, 38043, France

Location

Novartis Investigative Site

Lille, 59000, France

Location

Novartis Investigative Site

Lyon, 69275, France

Location

Novartis Investigative Site

Lyon, 69317, France

Location

Novartis Investigative Site

Mantes-la-Jolie, 78201, France

Location

Novartis Investigative Site

Marseille, 13008, France

Location

Novartis Investigative Site

Marseille, F 13008, France

Location

Novartis Investigative Site

Melun, 77000, France

Location

Novartis Investigative Site

Montauban, 82000, France

Location

Novartis Investigative Site

Montpellier, 34000, France

Location

Novartis Investigative Site

Mulhouse, 68070, France

Location

Novartis Investigative Site

Nantes, 44093, France

Location

Novartis Investigative Site

Nice, 06000, France

Location

Novartis Investigative Site

Paris, 75006, France

Location

Novartis Investigative Site

Paris, 75010, France

Location

Novartis Investigative Site

Paris, 75013, France

Location

Novartis Investigative Site

Paris, 75014, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Paris, 75940, France

Location

Novartis Investigative Site

Paris, F-75571, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Rouen, 76100, France

Location

Novartis Investigative Site

Saint-Jean, 31240, France

Location

Novartis Investigative Site

Saint-Priest-en-Jarez, 42270, France

Location

Novartis Investigative Site

Saitnt Herblain, 44819, France

Location

Novartis Investigative Site

Strasbourg, 67091, France

Location

Novartis Investigative Site

Toulouse, 31077, France

Location

Novartis Investigative Site

Tours, 37000, France

Location

Novartis Investigative Site

Tours, 37044, France

Location

Novartis Investigative Site

Vannes, 56000, France

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Edema; Glaucoma, Neovascular; Diabetic Retinopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Glaucoma; Ocular Hypertension; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

As the study was early terminated, no conclusion could be drawn from this study. The data should be interpreted with cautious as less than half of the patients included in the study (47.0%) completed the visit at Month 12.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2013
• First Posted: July 26, 2013
• Study Start: September 26, 2013
• Primary Completion: January 8, 2016
• Study Completion: January 8, 2016
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-07

Locations

FR (39)