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

Primary Purpose

Age-related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab 0.5mg
Sponsored by
Southern California Desert Retina Consultants, MC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-related Macular Degeneration focused on measuring amd, non-exudative macular degeneration, exudative macular degeneration, age-related macular degeneration, ranibizumab, anti-VEGF

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northern California Retina Vitreous Associates
  • Southern California Desert Retina Consultants
  • Elman Retina
  • Black Hills Regional Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Sham

Quarterly Ranibizumab 0.5mg

Arm Description

Sham Injection

Quarterly intravitreal injection of 0.5mg ranibizumab

Outcomes

Primary Outcome Measures

Development of exudative AMD
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

Vision change
Change in best-corrected visual acuity (BCVA) from baseline at 12 and 24 months
Vision loss
Proportion of eyes losing < 5, 10, and 15 letters on EDTRS chart at 12 and 24 months
Number of injections
Number of injections required in eyes that convert from dry to wet AMD during the study period
Baseline predictive factors
Baseline demographic, genetic and ocular characteristics predictive of development of wet AMD
Development of geographic atrophy (GA)
Development of geographic atrophy (GA) as detected by fundus photography (FP) and/or fundus autofluorescence (AF).
Ocular adverse events
Incidence and severity of ocular adverse events, as identified by eye examination and imaging
Systemic adverse events
Incidence and severity of other adverse events, as identified by physical examination or subject reporting.

Full Information

First Posted
April 25, 2014
Last Updated
August 23, 2022
Sponsor
Southern California Desert Retina Consultants, MC
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1. Study Identification

Unique Protocol Identification Number
NCT02140151
Brief Title
Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
Acronym
PREVENT
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 Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2014 (Actual)
Primary Completion Date
July 9, 2020 (Actual)
Study Completion Date
July 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern California Desert Retina Consultants, MC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
amd, non-exudative macular degeneration, exudative macular degeneration, age-related macular degeneration, ranibizumab, anti-VEGF

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
No Intervention
Arm Description
Sham Injection
Arm Title
Quarterly Ranibizumab 0.5mg
Arm Type
Active Comparator
Arm Description
Quarterly intravitreal injection of 0.5mg ranibizumab
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5mg
Other Intervention Name(s)
Lucentis
Primary Outcome Measure Information:
Title
Development of exudative AMD
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Vision change
Description
Change in best-corrected visual acuity (BCVA) from baseline at 12 and 24 months
Time Frame
2 years
Title
Vision loss
Description
Proportion of eyes losing < 5, 10, and 15 letters on EDTRS chart at 12 and 24 months
Time Frame
2 years
Title
Number of injections
Description
Number of injections required in eyes that convert from dry to wet AMD during the study period
Time Frame
2 years
Title
Baseline predictive factors
Description
Baseline demographic, genetic and ocular characteristics predictive of development of wet AMD
Time Frame
2 years
Title
Development of geographic atrophy (GA)
Description
Development of geographic atrophy (GA) as detected by fundus photography (FP) and/or fundus autofluorescence (AF).
Time Frame
2 years
Title
Ocular adverse events
Description
Incidence and severity of ocular adverse events, as identified by eye examination and imaging
Time Frame
2 years
Title
Systemic adverse events
Description
Incidence and severity of other adverse events, as identified by physical examination or subject reporting.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maziar Lalezary, MD
Organizational Affiliation
Southern California Desert Retina Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Southern California Desert Retina Consultants
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
Country
United States
Facility Name
Elman Retina
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States

12. IPD Sharing Statement

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Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration

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