A Phase 2 interventional study of ranibizumab in Macular Degeneration, sponsored by Steven R. Sanislo. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-06-29.
Sponsored by Steven R. Sanislo · Phase 2, Interventional, and Treatment
Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections.
Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails".
Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.
Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.
The duration of the study is up to 13 months. This includes up to 30 days during which tests will be performed before treatment. Only one eye will be chosen for the study. Patients can receive up to 12 injections of ranibizumab during this study (the first dose[s], plus additional doses [re treatment as often as every 22 days] if the doctor determines that additional doses are required).
In addition to study drug injections. Several eye examinations and procedures will be performed to evaluate response to treatment. These include: visual acuity testing (eye chart), contrast sensitivity testing, reading speed testing, measurement of time to complete typical daily activities, measurement of the thickness of the central retina, measurement of your central visual field.
On the screening visit and two more times during the study fluorescein angiography will be performed.
The screening tests included the following:
Upon completion of the study at Month 12 and if it were to occur; early termination visit, the following procedures will be performed: vision exam,OCT,microperimetry,FA/Photos,VFQ,reading performance, contrast sensitivity and TIADL.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 20 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →This is the only study on the registry with Steven R. Sanislo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects will be eligible if the following criteria are met:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
Group 1: 3 monthly injections of 0.5mg then prn
Drug: ranibizumab
Group 2: 6 monthly injections of 0.5 mg then prn
Drug: ranibizumab
Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months
Also known as: Lucentis
Mean Change in Visual Acuity
Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported.
Time frame: 12 months
| Milestone | Ranibizumab Group 1 | Ranibizumab Group 2 |
|---|---|---|
| Started | 8 | 12 |
| Completed | 8 | 11 |
| Not completed | 0 | 1 |
Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported.
| letters | Ranibizumab Group 1 | Ranibizumab Group 2 |
|---|---|---|
| Mean Change in Visual Acuity | 15.0 ± 14.2 | 5.6 ± 8.6 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ranibizumab Group 1 | — | 0/8 (0%) | 4/8 (50%) |
| Ranibizumab Group 2 | — | 0/12 (0%) | 4/12 (33.3%) |
| Event | Ranibizumab Group 1 | Ranibizumab Group 2 |
|---|---|---|
| laceration right legSkin and subcutaneous tissue disorders | 1/8 | 0/12 |
| laceration left legSkin and subcutaneous tissue disorders | 1/8 | 0/12 |
| Mild pneumoniaRespiratory, thoracic and mediastinal disorders | 1/8 | 0/12 |
| Seasonal allergiesImmune system disorders | 1/8 | 0/12 |
| Worsening glaucoma - which eye was not specifiedEye disorders | 1/8 | 0/12 |
| visual disturbance - fellow eyeEye disorders | 1/8 | 0/12 |
| development of choroidal neovascularization - fellow eyeEye disorders | 1/8 | 0/12 |
| bruised sturnumMusculoskeletal and connective tissue disorders | 1/8 | 0/12 |
| subconjuctival hemorrhage - treatment eyeEye disorders | 1/8 | 0/12 |
| intraretinal hemorrhage - treatment eyeEye disorders | 1/8 | 0/12 |
| Age, Categorical(Participants) | Ranibizumab Group 1 | Ranibizumab Group 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 8 | 12 | 20 |
| Age, Continuous(years) | Ranibizumab Group 1 | Ranibizumab Group 2 | Total |
|---|---|---|---|
| Mean | 81 (68 to 94) | 84 (71 to 97) | 83 (68 to 97) |
| Sex: Female, Male(Participants) | Ranibizumab Group 1 | Ranibizumab Group 2 | Total |
|---|---|---|---|
| Female | 3 | 8 | 11 |
| Male | 5 | 4 | 9 |
| Region of Enrollment(participants) | Ranibizumab Group 1 | Ranibizumab Group 2 | Total |
|---|---|---|---|
| United States | 8 | 12 | 20 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.