A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)

NCT01025232 | Terminated Phase 1 Results

• 1 other identifier: FVF4571s
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.

Conditions

Age Related Macular Degeneration; Choroidal Neovascular Membrane; Subfoveal Neovascular Age-Related Macular Degeneration; Macular Degeneration; Wet Age-Related Macular Degeneration

Keywords

Antibodies, Monoclonal; Immunologic Factors; Eye Diseases; Retinal Degeneration; Macular Degeneration; Pharmacologic Actions; Retinal Diseases

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in ETDRS BCVA at Month 12 (Fixed Interval Dosing Primary Endpoint After 3 Monthly Doses. Variable Interval Dosing Primary Endpoint at 1 Year.)

  Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS BCVA) was used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

  1 Year

Secondary Outcomes (6)

• Evaluate the Incidence and Severity of Ocular and Non-ocular Adverse Events (AEs) Through Month 12

  1 year

• Determine Number of Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12 and Month 12 in ETDRS BCVA

  1 year

• Determine Number of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12 in ETDRS BCVA.

  1 year

• Evaluate Mean Change in Central Retinal Thickness Over Time Through Month12 as Assessed by All Three OCTs (Stratus, Cirrus, and Spectralis)

  1 year

• Assess Number of Ranibizumab Injections in Each of the Two Doses Required Through Month 12

  1 year

Study Arms (2)

4 Week Re-treatment

ACTIVE COMPARATOR

Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.

Drug: Ranibizumab

6 Week Re-treatment

ACTIVE COMPARATOR

Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Intravitreal Injection of 2.0mg formulation

Also known as: Lucentis

4 Week Re-treatment; 6 Week Re-treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
• Age ≥ 50 years
• For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study
• Although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch. A patient's primary care physician, obstetrician, or gynecologist should be consulted regarding an appropriate form of birth control.
• Ability and willingness to return for all scheduled visits and assessments
• Study eyes must meet the following criteria for entry into the SAVE trial:
• The last treatment with Ranibizumab is ≥ 28 days
• To have received at least 9 injections of Ranibizumab in the past 12 months
• Any CNVM lesion (Occult, Minimally Classic or Classic) (i.e., leakage on fluorescein angiography or subretinal, intraretinal, or sub-RPE fluid on Spectral Domain OCT) secondary to age-related macular degeneration.
• Best corrected visual acuity in the study eye, using e-ETDRS testing, between 20/25 and 20/320 (Snellen equivalent), inclusive.
• Only one eye will be enrolled in the Study. If both eyes are eligible study investigator will select the eye for entry.
• The total area of subretinal hemorrhage and fibrosis must comprise less than 50% of the total lesion.
• Clear ocular media and adequate pupillary dilation to permit good quality fundus imaging

You may not qualify if:

• 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.
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial
• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
• Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye at a fluence equal to 100%, any fluence lower than 100% is permitted.
• Prior treatment with full or half fluence verteporfin PDT.
• Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs besides ranibizumab, or device implantation) in the study eye within the last 12 months.
• Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either \> 50% of the total area of the lesion or \> 1 disc area (2.54 mm2) in size
• Subfoveal fibrosis or atrophy in the study eye
• CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Concurrent Ocular Conditions
• Retinal pigment epithelial tear involving the fovea in the study eye
• 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 24-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 24-month study period.
• Active intraocular inflammation (grade trace or above) in the study eye
• Current vitreous hemorrhage in the study eye

Sponsors & Collaborators

• David M. Brown, M.D.: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Greater Houston Retina Research

Houston, Texas, 77030, United States

Location

Greater Houston Retina Research

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Eye Diseases; Retinal Degeneration; Retinal Diseases

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: David M. Brown, MD Director of Clinical Research
• Organization: Retinal Consultants of Houston

dmbmd@houstonretina.com

713-394-7534

Study Officials

• David M Brown, MD

  Greater Houston Retina Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Of Research

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 2, 2017
• Results First Posted: January 2, 2017

Record last verified: 2016-11

Locations

US (2)