Pilot Study to Evaluate the Safety and Efficacy of Treatment With ORA102 Combined With Avastin (Bevacizumab) Versus Avastin Alone, in Patients With Neovascular Age Related Macular Degeneration (AMD)

Study Overview
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Brief Summary
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This is s randomized, multi-center, double blind, 3 arm, phase I/II pilot study to evaluate the safety and efficacy of treatment with ORA102 combined with Avastin (Bevacizumab) versus Avastin alone, in patients with neo-vascular age related macular degeneration (AMD).

Official Title
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A Randomized, Multi-Center, Double Blind, 3 Arm, Phase I/II Pilot Study to Evaluate the Safety and Efficacy of Treatment With ORA102 Combined With Avastin (Bevacizumab) Versus Avastin Alone, in Patients With Neovascular Age Related Macular Degeneration (AMD)

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: ORA102 and Avastin
* Drug: Avastin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have provided informed consent, including signing of the informed consent form Subject who are able and willing to comply with the study protocol Subject must have best corrected visual acuity ETDRS between 20/40 to 20/320 in the study eye Subjects whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy Women must be post-menopausal 1 year or surgically sterilized. If not, negative serum pregnancy test required within 14 days of randomization Exclusion Criteria: Pregnant or lactating women Patients with severe myocardial disease or coronary occlusion Patients with severe personality disorder, suicidal risk or psychosis Patients with previous history of CVA Evidence for liver dysfunction - bilirubin level more than twice than upper limit of the normal value OR ALT/AST>1.5x upper limit of normal value Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of the investigational drugs or puts the patients in high risk for treatment related complications

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: ORA102 and Avastin<br>* treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102<br>|
| Active Comparator: 2<br> | Drug: ORA102 and Avastin<br>* treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102<br>|
| Placebo Comparator: 3<br> | Drug: Avastin<br>* treatment with intravitreal injections of Avastin 1.25mg (0.05ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of ocular adverse events, including retinal detachment, increase in IOP, cataract, tearing of the retina, decrease in vision, RPE atrophy, and vitreous hemorrhage, will be evaluated. |  | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32 |  | 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Avastin, ORA102, macular degeneration, neo-vascular age related macular degeneration (AMD)