Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01578720
Other study ID # KB-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2012
Est. completion date March 2015

Study information

Verified date August 2018
Source Retina Research Institute, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date March 2015
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- CNV of less than 1 year duration due to presumed ocular histoplasmosis

- Ability to provide written informed consent and comply with study assessments for the full duration of the study

- Age 21 years and older

- Subfoveal or juxtafoveal CNV lesion of less than 5400um in diameter

- Best corrected visual acuity of 20/25 to 20/400

- Birth control therapy for females of child-bearing age

Exclusion Criteria:

- CNV due to presumed ocular histoplasmosis for greater than 1 year

- Pregnancy (positive pregnancy test) or lactation

- Premenopausal women not using adequate contraception. The following are considered effective means of contraception : surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch

- A recent history of smoking (within 1 year of study enrollment)

- Prior treatment with intravitreal aflibercept injection

- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

- Uncontrolled glaucoma in the study eye (defined as IOP greater or equal to 30 mmHg despite treatment with anti-glaucoma medication)

- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment

- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

- Presence of significant subfoveal fibrosis or atrophy

- Intraocular surgery (including cataract surgery) in the study eye within 2 months of enrollment

- Active intraocular inflammation (grade trace or above) in the study eye

- History of allergy to fluorescein, ICG or iodine, not amendable to treatment

- Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either

- Require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or

- If allowed to progress untreated, could likely contribute to loss of at least 2 snellen equivalent lines of BCVA over the 12 month study period

- Prior/Concomitant Treatment:

- Panretinal photocoagulation treatment

- Previous intraocular steroids or PDT within 3 months

- Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)

- Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab) within 60 days

- Previous use of Macugen or Lucentis in study eye within 60 days

- Prior submacular or vitreous surgery

Study Design


Intervention

Drug:
EYLEA (Aflibercept) intravitreal injection
Intravitreal Injection once every 8 weeks with 3 initial monthly doses

Locations

Country Name City State
United States The Retina Institute Saint Louis Missouri
United States The Retina Institute Saint Louis Missouri
United States The Retina Institute Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Retina Research Institute, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety The Incidence & Severity will be assessed during study participation. Baseline medical conditions & abnormal findings present prior to the patient signing the Informed Consent Form (ICF)will be recorded as pre-existing illnesses in the medical history. Clinical study staff will start assessing subjects for adverse events once the ICF has been signed starting at month 1 and at each monthly visit,and will be instructed to request the adverse event information in a nonspecific, non-suggestive type of questioning. The Investigators will record all adverse events regardless of causality. 12 months
Secondary Mean visual acuity (BCVA) at Months 6 and 12 Month 6 and Month 12
Secondary Mean change in OCT central foveal thickness from baseline at Months 6 and 12 Months 6 and 12
Secondary Mean change in Macular Volume from baseline at Months 6 and 12 Months 6 and 12
Secondary Mean change in visual acuity (BCVA) from baseline at Months 6 and 12 Months 6 and 12
Secondary Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12 Months 6 and 12
Secondary Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12 Months 6 and 12
See also
  Status Clinical Trial Phase
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Withdrawn NCT01666236 - Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy Phase 4
Completed NCT02015351 - Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study N/A
Completed NCT01175395 - 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) Phase 1/Phase 2
Terminated NCT00712491 - Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00533520 - Evaluation of Dosing Interval of Higher Doses of Ranibizumab Phase 4
Completed NCT00242580 - A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib Phase 3
Completed NCT04075188 - Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid N/A
Not yet recruiting NCT05055973 - OCTA Insights in CNVM, Morphological Characteristics and Correlation With Structural OCT.
Recruiting NCT00568191 - Stratus Versus Cirrus OCT in AMD N/A
Completed NCT01256632 - Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy N/A
Recruiting NCT00100087 - Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System Phase 1/Phase 2
Completed NCT04455399 - Time Efficiency Comparison of Two IntraVitreal Injection Techniques N/A
Terminated NCT02857894 - Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)
Not yet recruiting NCT02934841 - Conbercept in Choroidal Neovascularization Secondary to Uveitis Phase 2
Completed NCT01880788 - Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD N/A
Completed NCT00775411 - Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD) Phase 2
Completed NCT00604071 - Sensitivity of the Home Macular Perimeter (HMP) N/A
Withdrawn NCT00403156 - Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration Phase 1
Completed NCT00406250 - Intravitreal Bevacizumab in Agioid Streaks Phase 1