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Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration (PREVENT)

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ClinicalTrials.gov Identifier: NCT02140151
Recruitment Status : Unknown
Verified August 2016 by Southern California Desert Retina Consultants, MC.
Recruitment status was:  Recruiting
First Posted : May 16, 2014
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Southern California Desert Retina Consultants, MC

Brief Summary:
This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: Ranibizumab 0.5mg Phase 1 Phase 2

Detailed Description:

This is a multicenter, prospectively randomized, masked and controlled, interventional investigator sponsored phase I/II study of subjects with high-risk nonexudative age-related macular degeneration (AMD) treated with intravitreal ranibizumab quarterly for prophylaxis of conversion to exudative age-related macular degeneration.

The objective of this study is to investigate the safety and efficacy of prophylactic anti-vascular endothelial growth factor (VEGF) therapy with ranibizumab to prevent the development of exudative AMD in eyes with high-risk nonexudative AMD. In addition, baseline characteristics of high-risk eyes (fundus features, optical coherence tomography (OCT) parameters and genetic profile) will be evaluated to determine their predictive value in conversion to exudative AMD. The effect of ranibizumab on the atrophic component of AMD will also be monitored.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration (AMD) in Vulnerable Eyes With Nonexudative AMD Trial: A Multicenter, Prospectively Randomized, Masked and Controlled, Interventional Investigator Sponsored Phase I/II Study
Study Start Date : September 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
No Intervention: Sham
Sham Injection
Active Comparator: Quarterly Ranibizumab 0.5mg
Quarterly intravitreal injection of 0.5mg ranibizumab
Drug: Ranibizumab 0.5mg
Other Name: Lucentis




Primary Outcome Measures :
  1. Development of exudative AMD [ Time Frame: 2 years ]
    Development of choroidal neovascularization (conversion) defined by the presence of leakage on fluorescein angiography (FA) and fluid within or below the retina or below the retinal pigment epithelium seen on spectral-domain optical coherence tomography (SD-OCT)


Secondary Outcome Measures :
  1. Vision change [ Time Frame: 2 years ]
    Change in best-corrected visual acuity (BCVA) from baseline at 12 and 24 months

  2. Vision loss [ Time Frame: 2 years ]
    Proportion of eyes losing < 5, 10, and 15 letters on EDTRS chart at 12 and 24 months

  3. Number of injections [ Time Frame: 2 years ]
    Number of injections required in eyes that convert from dry to wet AMD during the study period

  4. Baseline predictive factors [ Time Frame: 2 years ]
    Baseline demographic, genetic and ocular characteristics predictive of development of wet AMD

  5. Development of geographic atrophy (GA) [ Time Frame: 2 years ]
    Development of geographic atrophy (GA) as detected by fundus photography (FP) and/or fundus autofluorescence (AF).

  6. Ocular adverse events [ Time Frame: 2 years ]
    Incidence and severity of ocular adverse events, as identified by eye examination and imaging

  7. Systemic adverse events [ Time Frame: 2 years ]
    Incidence and severity of other adverse events, as identified by physical examination or subject reporting.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult over 50 years old
  • Able to sign informed consent and comply with the study protocol for the duration of two years
  • Nonexudative age-related macular degeneration (AMD) in one eye (study eye)
  • History of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment

Exclusion Criteria:

  • Participation in another simultaneous medical investigation or clinical trial
  • Patient is pregnant, lactating, or premenopausal and not using adequate contraception
  • Known serious allergies to ranibizumab, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine solution)
  • Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc.
  • History of vitrectomy in the study eye
  • History of cataract surgery within 3 months of enrollment
  • History of yttrium aluminum garnet (YAG) capsulotomy within 1 month of enrollment
  • History of intraocular or periocular corticosteroid therapy within the past 90 days
  • History of therapeutic radiation in the region of the study eye.
  • Presence of media opacity that would preclude adequate examination and/or imaging
  • Concurrent macular conditions that would affect the study parameters (epiretinal membrane, macular hole, macular edema) or require treatment within the duration of the study
  • Any progressive ocular condition (uncontrolled glaucoma, diabetic retinopathy, uveitis) that may affect the visual acuity for the duration of the study
  • Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at enrollment
  • Presence of any advanced systemic condition that may hinder the patients participation and completion of the study
  • Concurrent use of systemic anti-VEGF therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140151


Contacts
Contact: Maziar Lalezary, MD 760-340-2394 mlalezary@desertretina.com

Locations
United States, California
Northern California Retina Vitreous Associates Recruiting
Mountain View, California, United States, 94040
Contact: Sharon Depaz    650-988-7480    sdepaz@ncrva.com   
Sub-Investigator: Alok Bansal, MD         
Sub-Investigator: Mark Wieland, MD         
Sub-Investigator: Rahul Khurana, MD         
Sub-Investigator: Louis Chang, MD         
Sub-Investigator: Jim Palmer, MD         
Southern California Desert Retina Consultants Recruiting
Palm Desert, California, United States, 92211
Contact: Kim Walther    760-340-2394 ext 229    kwalther@desertretina.com   
Contact: Maziar Lalezary, MD    760-340-2394    mlalezary@desertretina.com   
Principal Investigator: Maziar Lalezary, MD         
Sub-Investigator: Clement K Chan, MD         
Sub-Investigator: Steven G Lin, MD         
United States, Maryland
Elman Retina Recruiting
Baltimore, Maryland, United States, 21237
Contact: Jennifer Belz    410-553-9095    belz@elmanretina.com   
Contact: Joann Starr    410-553-9095    starr@elmanretina.com   
Principal Investigator: Michael Elman, MD         
United States, South Dakota
Black Hills Regional Eye Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Kristi Livermont    605-719-3307    klivermont@bhrei.com   
Sub-Investigator: Prema Abraham, MD         
Sub-Investigator: Arunan Sivalingam, MD         
Sponsors and Collaborators
Southern California Desert Retina Consultants, MC
Investigators
Principal Investigator: Maziar Lalezary, MD Southern California Desert Retina Consultants

Responsible Party: Southern California Desert Retina Consultants, MC
ClinicalTrials.gov Identifier: NCT02140151     History of Changes
Other Study ID Numbers: ML29258
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Southern California Desert Retina Consultants, MC:
amd
non-exudative macular degeneration
exudative macular degeneration
age-related macular degeneration
ranibizumab
anti-VEGF

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents