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

Phase 3

Completed

• Conditions: Glaucoma, Neovascular; Choroidal Neovascularization; Diabetic Retinopathy; Macular Edema
• Interventions: Drug: ranibizumab

• Registration Number: NCT01908816
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-20
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-26
• Study Start: 2013-09-26
• Primary Completion: 2016-01-08
• Study Completion: 2016-01-08
• Results First Submitted: 2017-05-09
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-02
• Last Update Submitted: 2019-07-02
• Results First Posted: 2019-08-12
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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

Exclusion Criteria

• wet Age-related macular degeneration
• pathologic myopia
• pseudoxanthoma elasticum
• diabetic macular edema
• retinal vein occlusion
• < 18 years of age
• History of hypersensitivity to ranibizumab
• Use of any systemic anti-angiogenic drugs 3 months before inclusion
• Women of child-bearing potential and Pregnant or nursing (lactating) women.
• Active or suspected ocular infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)	3 months, 12 months	BCVA change for diseases affecting the macular area either through CNV or ME. BCVA is tested using the ETDRS (Early Treatment Diabetic Retinopathy Study), the Snellen or Monoyer scales. The three scales are designed to measure visual acuity. ETDRS score is expressed in letter, Snellen and Monoyer score in fraction. BCVA assessment is presented in ETDRS after conversion if collected in Snellen or Monoyer. (Monoyer converted to Snellen = 2 x (Monoyer fraction) and Snellen converted to approximate ETDRS letters = 1x log(Snellen fraction). ETDRS letter score was transformed in logMAR unit for statistical analysis (- LogMAR = -(ETDRS-85)/50). The worse ETDRS letter score is 0 (logMAR 2.3) and the best ETDRS letter score is 100 (logMAR -0.3).
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma	3 month, 12 month	The extent of iris neovascularization was assessed by iris photography and graded using the "Teich and Walsh grading system". This grading system measures the number of quadrant at iris pupillary zone or iris ciliary zone where iris neovascularization (NV) is observed.; Grade 0 = "No iris vascularization", Grade 1= Less than 2 quadrants of NV at iris pupillary zone, Grade 2 = More than 2 quadrants of NV at iris pupillary zone, Grade 3 =Grade 2 + less than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae; Grade 4 =More than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae)
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy	3 months, 12 month	Occurrence of postoperative vitreous cavity hemorrhage
Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"	3 months, 12 month	CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area
Proportion of Patients With Angiographic Leakage	3 months, 12 month	Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 3. Also any decreases of angiographic leakage was counted between baseline and 3 month.
Ranibizumab Injection	3 months, 12 month	Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇷 Vannes, France