An Open-Label Investigator Sponsored Trial to Investigate the Safety, Tolerability and Development of Subfoveal Fibrosis By Intravitreal Administration of Altering Regimens of Fovista and Anti-VEGF Therapy in Subjects With Neovascular Age-Related Macular Degeneration
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|ClinicalTrials.gov Identifier: NCT02591914|
Recruitment Status : Unknown
Verified October 2015 by Pravin Dugel, MD, Retinal Consultants of Arizona.
Recruitment status was: Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : October 30, 2015
The objectives of this study are to establish the safety and tolerability of intravitreous administration of altering regimens of Fovista™ (Anti-PDGF-B pegylated aptamer) administered in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with subfoveal neovascular age-related macular degeneration.
Subjects will be treated with Fovista™ and Anti-VEGF therapy every month for the first three months. Retreatment with Fovista™ and Anti-VEGF will occur if the following findings are present PER INVESTIGATOR DISCRETION:
- ≥ 5 ETDRS letters loss OR;
- Significant hemorrhage OR;
- New or increased RPE elevation consistent with increased disease activity OR;
- Increased neovascular lesion size OR;
- New or increased foveal intraretinal fluid
If anti-VEGF re-treatment is not administered based on the re-treatment criteria noted above, Fovista™ anti-PDGF therapy MUST be administered at a minimum of every 3 months (as monotherapy).
Therefore, subjects will be treated with Fovista™ or Anti-VEGF therapy for a total of 3-24 administrations.
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-Related Macular Degeneration||Drug: Fovista™ Drug: Lucentis® Drug: Avastin® Drug: Eylea®||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
Experimental: Altering regimens of Fovista™and Anti-VEGF Therapy
All subjects will be treated with Fovista™ 1.5 mg/eye in combination with anti-VEGF therapy.
The following doses of Anti-VEGF therapy will be delivered based on the Investigator's discretion:
Subjects will be treated with Fovista™ and Anti-VEGF therapy every month for the first three months.
The regimen for administration of each intravitreal agent will be as follows:
Injection Day #1-Administration of Fovista™ 1.5mg/eye
Injection Day #2-Administration of Fovista™ 1.5mg/eye followed by anti-VEGF therapy after Fovista™ injection
The same regimen will be delivered monthly until the subject reaches maximum visual acuity benefit. Maximum visual acuity is defined as no increase in ETDRS visual acuity at two consecutive visits.
Subsequent re-treatment with the Anti-VEGF therapy will use a PRN ("as-needed") regimen based on protocol specified retreatment criteria.
Anti-PDGF-B pegylated aptamerDrug: Lucentis®
- Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables. [ Time Frame: Month 24 ]
- Mean change in amount of fibrosis as assessed by fundus photography and OCT evaluation. [ Time Frame: Month 24 ]
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): NCT02591914
|United States, Arizona|
|Retinal Consultants of Arizona|
|Phoenix, Arizona, United States, 85014|